BRAEMAR CARDIOKEY HOLTER RECORDER— 510(k) K130294

Substantially Equivalent

Braemar Manufacturing, LLC

FDA 510(k) clearance K130294 for BRAEMAR CARDIOKEY HOLTER RECORDER, Substantially Equivalent on 2013-10-16. Applicant: Braemar Manufacturing, LLC.

Clearance details

Applicant: Braemar Manufacturing, LLC
Product code: Code MWJ
Advisory panel: Cardiovascular
Date received: 2013-02-06
Decision date: 2013-10-16
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWJ

product code MWJ

Other: 1
Total: 1

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.