The following data is part of a premarket notification filed by Bardy Diagnostics, Inc. with the FDA for Carnation Ambulatory Monitor (cam).
| Device ID | K210036 |
| 510k Number | K210036 |
| Device Name: | Carnation Ambulatory Monitor (CAM) |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | Bardy Diagnostics, Inc. 316 Occidental Avenue South Suite B310 Seattle, WA 98104 |
| Contact | Jocelyn Kersten |
| Correspondent | Jocelyn Kersten Bardy Diagnostics, Inc. 316 Occidental Avenue South Suite B310 Seattle, WA 98104 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-06 |
| Decision Date | 2021-02-05 |