510(k) K130921— ALIVECOR HEART MONITOR OTC

Substantially Equivalent

AliveCor, Inc.

Clearance details

Applicant: AliveCor, Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2013-04-03
Decision date: 2014-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.