đź“‹ FDA Reference

philips sp02 disposable sensor model m1131a

Philips Medizin Systeme Boeblingen

Summary: The Philips SpO2 Disposable Sensor M1131A is a medical device used to monitor blood oxygen saturation levels. It is typically used by healthcare professionals in various clinical settings to ensure accurate patient monitoring.

FDA Clearance Information

Pathway 510K
Decision Date October 15, 2004
Product Code DQA
Device Class Class 2
Evidence 419 studies

The Philips SpO2 Disposable Sensor M1131A was cleared through the FDA 510(k) pathway on October 15, 2004. It is manufactured by Philips Medizin Systeme Boeblingen and is classified as a Class 2 medical device.

What It Is

The Philips SpO2 Disposable Sensor M1131A is a disposable sensor designed to measure peripheral oxygen saturation (SpO2) in patients. It works by emitting light through a patient's skin and measuring the amount of light absorbed by oxygenated and deoxygenated hemoglobin. This non-invasive device provides continuous monitoring of oxygen saturation, which is crucial for assessing respiratory function.

Clinical Applications

This sensor is commonly used in hospital settings, including intensive care units, operating rooms, and emergency departments. It is essential for monitoring patients with respiratory conditions, during anesthesia, and in critical care situations. The device is suitable for use in both adult and pediatric populations, providing flexibility across various clinical scenarios.

Indications for Use

The FDA-cleared indications for this device include monitoring oxygen saturation levels in patients who require continuous or intermittent monitoring. It is particularly useful for patients with respiratory or cardiovascular conditions where oxygen saturation monitoring is critical.

Practical Considerations

The Philips SpO2 Disposable Sensor M1131A is designed for single-patient use to prevent cross-contamination. It is compatible with specific Philips monitoring systems, and clinicians should ensure proper sensor placement for accurate readings. The sensor is available in different sizes to accommodate various patient demographics.

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

Editorial - Philippe Ascher (1936-2022).

Neuroscience

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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 the Philips SpO2 Disposable Sensor M1131A used for?

It is used to monitor blood oxygen saturation levels in patients, providing continuous or intermittent monitoring as needed.

What specialties typically use this device?

Specialties such as anesthesiology, critical care, emergency medicine, and respiratory therapy commonly use this device.

What are the FDA-cleared indications?

The device is indicated for monitoring oxygen saturation levels in patients, particularly those with respiratory or cardiovascular conditions.

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.

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