The following data is part of a premarket notification filed by Heartforce Medical, Inc. with the FDA for Digital Ballistocardiograph, Model Dgb 300.
| Device ID | K081603 |
| 510k Number | K081603 |
| Device Name: | DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 |
| Classification | Ballistocardiograph |
| Applicant | HEARTFORCE MEDICAL, INC. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Contact | Arthur Ward |
| Correspondent | Arthur Ward HEARTFORCE MEDICAL, INC. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Product Code | DXR |
| CFR Regulation Number | 870.2320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-06 |
| Decision Date | 2009-07-24 |
| Summary: | summary |