The following data is part of a premarket notification filed by Braveheart Wireless, Inc. with the FDA for Life Sensor Cardiac Monitor.
| Device ID | K191331 |
| 510k Number | K191331 |
| Device Name: | Life Sensor Cardiac Monitor |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | BraveHeart Wireless, Inc. 11 Perimeter Road Nashua, NH 03063 |
| Contact | Balaji Sudabattula |
| Correspondent | Thomas Schorre Accelerated Device Approval Services, LLC 6800 S.W. 40th Street, Ste. 444 Ludlum, FL 33155 -3708 |
| Product Code | DRG |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DRX |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-05-16 |
| Decision Date | 2019-06-12 |