ePatch— 510(k) K171410

Name: FDA 510(k) clearance K171410
Creator: U.S. Food and Drug Administration
Published: 2018-01-04

Substantially Equivalent

Braemar Manufacturing, LLC

FDA 510(k) clearance K171410 for ePatch, Substantially Equivalent on 2018-01-04. Applicant: Braemar Manufacturing, LLC. Device class: 2.

Clearance details

Applicant: Braemar Manufacturing, LLC
Product code: Code DSH
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2017-05-15
Decision date: 2018-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.