HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME— 510(k) K111159
Substantially EquivalentCardiocomm Solutions, Inc.
FDA 510(k) clearance K111159 for HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME, Substantially Equivalent on 2011-12-22. Applicant: Cardiocomm Solutions, Inc..
Clearance details
- Applicant
- Cardiocomm Solutions, Inc.
- Product code
- Code DPS
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Appollo Beach, FL, US
Adverse events under product code DPS
product code DPS- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . 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.