The following data is part of a premarket notification filed by Cardio Comm Solutions, Inc. with the FDA for Heartcheck Pen Handheld Ecg With Gems Home.
| Device ID | K111159 |
| 510k Number | K111159 |
| Device Name: | HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME |
| Classification | Electrocardiograph |
| Applicant | CARDIO COMM SOLUTIONS, INC. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Contact | Jonathan Ward |
| Correspondent | Jonathan Ward CARDIO COMM SOLUTIONS, INC. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-25 |
| Decision Date | 2011-12-22 |
| Summary: | summary |