FDA 510(k)

ePatch

K-Number: K171410 · 2018-01-04

Decision Date2018-01-04

Product CodeDSH

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ePatch is the device name listed in this FDA 510(k) record. The listed applicant is Braemar Manufacturing, LLC. It received FDA 510(k) clearance on 2018-01-04 under 510(k) 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. The listed applicant is Braemar Manufacturing, LLC. The 510(k) number is K171410.

When did ePatch receive FDA 510(k) clearance?

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

Who is the listed applicant for ePatch?

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

What is the FDA product code for ePatch?

The FDA product code for ePatch is DSH.

Other records listing Braemar Manufacturing, LLC as applicant

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.

K153473Braemar Telemetry Patch System

Related Devices (Code: DSH)

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.

Official Source

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