HEARTCHECK ECG PEN WITH GEMS HOME— 510(k) K121009

Substantially Equivalent

Cardiocomm Solutions, Inc.

FDA 510(k) clearance K121009 for HEARTCHECK ECG PEN WITH GEMS HOME, Substantially Equivalent on 2012-05-17. Applicant: Cardiocomm Solutions, Inc..

Clearance details

Applicant: Cardiocomm Solutions, Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2012-04-03
Decision date: 2012-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Appollo Beach, FL, US

Download summary PDF View on FDA.gov ↗

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.