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FDA 510(k)

ePatch

K-Number: K171410 · 2018-01-04

ApplicantBraemar Manufacturing, LLC
Decision Date2018-01-04
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ePatch is a medical device manufactured by Braemar Manufacturing, LLC. It received FDA 510(k) clearance on 2018-01-04 under approval number K171410. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ePatch?

ePatch is a medical device that received FDA 510(k) clearance on 2018-01-04. It is manufactured by Braemar Manufacturing, LLC. The 510(k) number is K171410.

When was ePatch approved by the FDA?

ePatch received FDA 510(k) clearance on 2018-01-04, under approval number K171410.

What company makes ePatch?

ePatch is manufactured by Braemar Manufacturing, LLC.

What is the FDA product code for ePatch?

The FDA product code for ePatch is DSH.

Other Devices by Braemar Manufacturing, LLC

K153473Braemar Telemetry Patch System

Related Devices (Code: DSH)

K162571Bioflux SoftwareBiotricity, Inc. K160704myPatch-sDms-Service, LLC K171936Peerbridge Cor(TM) SystemPeerbridge Health, Inc. K162503Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView SoftwareCardiac Insight, Inc. K163535my Patch slDms-Service, LLC K173461ECG recorder and Arrhythmia DetectorSmart Solutions Technologies SL

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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