The following data is part of a premarket notification filed by Bardy Diagnostics, Inc with the FDA for Carnation Ambulatory Monitor.
| Device ID | K191471 |
| 510k Number | K191471 |
| Device Name: | Carnation Ambulatory Monitor |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | Bardy Diagnostics, Inc 316 Occidental Avenue South, Suite B310 Seattle, WA 98104 |
| Contact | Brit Baird |
| Correspondent | Brit Baird 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 | 2019-06-03 |
| Decision Date | 2019-08-30 |