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 |