BioMonitor— 510(k) K143503

Substantially Equivalent

Biotronik, Inc.

FDA 510(k) clearance K143503 for BioMonitor, Substantially Equivalent on 2015-03-19. Applicant: Biotronik, Inc..

Clearance details

Applicant: Biotronik, Inc.
Product code: Code MXD
Advisory panel: Cardiovascular
Date received: 2014-12-10
Decision date: 2015-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Oswego, OR, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MXD

product code MXD

Injury: 1,880
Malfunction: 9,487
Total: 11,367

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.