The following data is part of a premarket notification filed by Bardy Diagnostics, Inc. with the FDA for Carnation Ambulatory Monitor.
| Device ID | K143067 |
| 510k Number | K143067 |
| Device Name: | Carnation Ambulatory Monitor |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | BARDY DIAGNOSTICS, INC. 17141 VASHON HIGHWAY, SW. Vashon Island, WA 98070 |
| Contact | Jon P. Hunt |
| Correspondent | Jon P. Hunt BARDY DIAGNOSTICS, INC. 17141 VASHON HIGHWAY, SW. Vashon Island, WA 98070 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-24 |
| Decision Date | 2014-12-22 |