ER800 SERIES ECG EVENT RECORDER— 510(k) K030856

Substantially Equivalent

Braemar Corp.

FDA 510(k) clearance K030856 for ER800 SERIES ECG EVENT RECORDER, Substantially Equivalent on 2003-03-28. Applicant: Braemar Corp..

Clearance details

Applicant: Braemar Corp.
Product code: Code MWJ
Advisory panel: Cardiovascular
Date received: 2003-03-18
Decision date: 2003-03-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Burnsville, MN, 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.