đź“‹ FDA Reference
philips reusable ecg lead sets and trunk cables model number model name 989803170171 or 3-lead ecg trunk cable aami iec 989803170181 or 5-lead ecg trunk cable aami iec m1667a 6 lead ecg trunk aami iec 2 7m m1668a 5 lead ecg trunk aami iec 2 7m m1669a 3 lead ecg trunk aami iec 2 7m m1949a 5 5 ecg trunk cable aami iec 2 7m m1663a 10 lead ecg trunk aami iec 2m m1665a 6 4 lead ecg trunk aami iec 2 7m m1671a 3 leadset grabber aami icu m1673a 3 leadset sn
Philips Medizin Systeme Boblingen
Summary: Philips reusable ECG lead sets and trunk cables are used for monitoring cardiac activity in patients. They are typically used by cardiologists and healthcare professionals in hospitals and clinics.
FDA Clearance Information
Pathway
510K
Number
K243545 ↗
Decision Date
January 17, 2025
Product Code
DSA
Device Class
Class 2
Evidence
419 studies
This device was cleared through the FDA 510k pathway on January 17, 2025. It is manufactured by Philips Medizin Systeme Boblingen and classified as a Class 2 device.
What It Is
The Philips reusable ECG lead sets and trunk cables are medical devices used to monitor the electrical activity of the heart. They are designed to be durable and reusable, providing reliable ECG signals for accurate cardiac assessment. These devices connect to ECG machines, allowing clinicians to obtain detailed heart rhythm information.
Clinical Applications
These ECG lead sets are commonly used in cardiology departments, intensive care units, and emergency settings. They are essential for diagnosing arrhythmias, monitoring heart conditions, and guiding treatment decisions in patients with cardiac issues. The devices are suitable for adult and pediatric patients in both inpatient and outpatient settings.
Indications for Use
The FDA indications suggest these devices are intended for monitoring and recording the electrical activity of the heart. They are used in patients who require cardiac monitoring, such as those with suspected heart disease or undergoing cardiac procedures.
Practical Considerations
These ECG lead sets are available in various configurations, including 3-lead, 5-lead, and 10-lead options, to suit different clinical needs. They are compatible with standard ECG machines and require proper placement technique to ensure accurate readings. Regular cleaning and maintenance are necessary to ensure longevity and performance.
Related Literature
The linked study, titled 'SpO2 Validation Study-Philips Optimus,' appears to focus on the validation of SpO2 measurements, although specific details are not available. Key findings and limitations are not provided, which limits the ability to draw conclusions about its relevance to the ECG lead sets.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →
PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →
PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →
PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →
PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →
PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →
PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →
PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →
PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is Philips reusable ECG lead sets used for?
They are used for monitoring and recording the electrical activity of the heart in various clinical settings.
What specialties typically use this device?
Cardiology, emergency medicine, and intensive care units commonly use these devices.
What are the FDA-cleared indications?
The devices are indicated for monitoring cardiac activity in patients requiring ECG assessment.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.