Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Epiwatch, Inc.. It received FDA 510(k) clearance on 2025-03-07 under 510(k) 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. The listed applicant is Epiwatch, Inc.. The 510(k) number is K243515.

When did EpiWatch Monitoring System receive FDA 510(k) clearance?

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

Who is the listed applicant for EpiWatch Monitoring System?

The FDA 510(k) record lists Epiwatch, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EpiWatch Monitoring System?

The FDA product code for EpiWatch Monitoring System is POS.

Related Devices (Code: POS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251506Nelli (Version 7.11)Neuro Event Labs OYK243199NightWatch+ USLivassured BVK250515EpiMonitorEmpatica S.r.l.K232915EpiMonitorEmpatica S.r.l.K200276SPEAC SystemBrain Sentinel, Inc.K182180SPEAC SystemBrain Sentinel, Inc.

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.

↑