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FDA 510(k)

EpiWatch Monitoring System

K-Number: K243515 · 2025-03-07

ApplicantEpiwatch, Inc.
Decision Date2025-03-07
Product CodePOS
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EpiWatch Monitoring System is a medical device manufactured by Epiwatch, Inc.. It received FDA 510(k) clearance on 2025-03-07 under approval number K243515. The device is classified under product code POS. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EpiWatch Monitoring System?

EpiWatch Monitoring System is a medical device that received FDA 510(k) clearance on 2025-03-07. It is manufactured by Epiwatch, Inc.. The 510(k) number is K243515.

When was EpiWatch Monitoring System approved by the FDA?

EpiWatch Monitoring System received FDA 510(k) clearance on 2025-03-07, under approval number K243515.

What company makes EpiWatch Monitoring System?

EpiWatch Monitoring System is manufactured by Epiwatch, Inc..

What is the FDA product code for EpiWatch Monitoring System?

The FDA product code for EpiWatch Monitoring System is POS.

Related Clinical Trials

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41619565 Integration of materiovigilance in Unani medicine: A step towards patient safety. Journal of Ayurveda and integrative medicine (2026) PMID: 41491965 From stones to system: integrating kidney stones disease into the cardiovascular-kidney-metabolic continuum. Current opinion in nephrology and hypertension (2026)

Related Devices (Code: POS)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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