The following data is part of a premarket notification filed by Cardiocomm Solutions, Inc. with the FDA for Globalcardio.
| Device ID | K111320 |
| 510k Number | K111320 |
| Device Name: | GLOBALCARDIO |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | CARDIOCOMM SOLUTIONS, INC. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Contact | Jon Ward |
| Correspondent | Jon Ward CARDIOCOMM SOLUTIONS, INC. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-10 |
| Decision Date | 2011-10-07 |
| Summary: | summary |