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the m3810a philips telemonitoring system with m3814a spo2 unit
Philips Medical Systems
Summary: The m3810a Philips Telemonitoring System is a device designed for remote patient monitoring, particularly in home settings. It is primarily used for managing patients requiring noninvasive ventilation. Key evidence highlights its role in improving patient management and adherence.
FDA Clearance Information
Pathway
510K
Number
K041674 ↗
Decision Date
July 19, 2004
Product Code
DQA
Device Class
Class 2
Evidence
419 studies
The m3810a Philips Telemonitoring System was cleared by the FDA through the 510(k) pathway on July 19, 2004. It is manufactured by Philips Medical Systems and classified as a Class 2 device.
What It Is
The m3810a Philips Telemonitoring System, with the m3814a SpO2 unit, is a telemonitoring device designed to remotely monitor patients' vital signs, particularly oxygen saturation. It is intended for use in home settings to assist in the management of patients requiring noninvasive ventilation.
Clinical Applications
This device is commonly used in scenarios where patients require continuous monitoring of oxygen levels, such as in cases of chronic respiratory conditions. It provides clinicians with real-time data to manage and adjust treatment plans remotely.
Evidence Summary
The available literature includes 10 studies, with a mix of RCTs, prospective, and retrospective designs, spanning from 2023 to 2025. These studies explore the device's impact on patient management and adherence to treatment protocols.
Reported Outcomes
Published studies report that the m3810a Philips Telemonitoring System improves adherence to noninvasive ventilation protocols and assists in early identification of inadequate ventilation. It has been shown to facilitate better management of chronic respiratory conditions in home settings.
Safety Profile
Reported complications include potential issues with data transmission and occasional inaccuracies in SpO2 readings. However, no severe adverse events directly related to the device have been documented in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies specifically focused on this device. Further research is needed to explore long-term outcomes and to validate findings across diverse patient populations.
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 noninvasive ventilation, particularly in home settings.
What outcomes have been reported in clinical studies?
Studies have reported improved adherence to ventilation protocols and better management of chronic respiratory conditions.
What complications have been reported?
Safety data indicate potential issues with data transmission and SpO2 reading inaccuracies, but no severe 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.