510(k) K111159
K111159 is an FDA 510(k) premarket notification submitted by Cardiocomm Solutions, Inc. for the device "HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME". The FDA issued a decision of Substantially Equivalent on Dec 22, 2011. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Cardiocomm Solutions, Inc. has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 22, 2011
- Date Received
- Apr 25, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2340
- Review Panel
- CV
- Submission Type
- 510(k)