đź“Š Evidence-Based Reference
the m3810a philips telemonitoring system with m3812b telestation m310a 12b
Philips Medical Systems
Summary: The m3810a Philips Telemonitoring System is designed for remote patient monitoring, primarily used in managing home noninvasive ventilation. Key evidence highlights its role in identifying inadequate ventilation.
FDA Clearance Information
Pathway
510K
Number
K023749 ↗
Decision Date
November 19, 2002
Product Code
DRG
Device Class
Class 2
Evidence
419 studies
The m3810a Philips Telemonitoring System was cleared by the FDA via the 510(k) pathway on November 19, 2002. It is manufactured by Philips Medical Systems and classified as a Class 2 device.
What It Is
The m3810a Philips Telemonitoring System is a telemonitoring device used to remotely monitor patients' physiological parameters. It is intended for use in home settings to assist in the management of patients requiring noninvasive ventilation.
Clinical Applications
Commonly used in home healthcare settings, this device aids in the management of patients with chronic respiratory conditions requiring noninvasive ventilation. It provides clinicians with real-time data to adjust treatment plans as needed.
Evidence Summary
The literature includes 10 studies, comprising RCTs, prospective, and retrospective analyses, published between 2023 and 2025. These studies explore the device's role in telemonitoring and hypertension management.
Reported Outcomes
Published studies report that the m3810a Philips Telemonitoring System effectively identifies patients with inadequate ventilation, potentially reducing healthcare costs. It also supports hypertension management by facilitating home blood pressure monitoring.
Safety Profile
Reported complications include issues related to data accuracy and patient adherence to device usage. No significant adverse events directly linked to the device have been documented in the available studies.
Evidence Limitations
The evidence is limited by small sample sizes and short follow-up periods. Further research is needed to explore long-term outcomes and the device's impact on patient quality of life.
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 are the clinical indications for the m3810a Philips Telemonitoring System?
The device is indicated for remote monitoring of patients requiring home noninvasive ventilation and management of hypertension.
What outcomes have been reported in clinical studies?
Studies have reported improved identification of inadequate ventilation and potential cost savings in healthcare management.
What complications have been reported?
Safety data indicate potential issues with data accuracy and patient adherence, but no major adverse events have been reported.
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.