K191000 is an FDA 510(k) clearance for the Carnation Ambulatory Monitor. This device is classified as a Recorder, Magnetic Tape, Medical (Class II - Special Controls, product code DSH).
Submitted by Bardy Diagnostics, Inc. (Seattle, US). The FDA issued a Cleared decision on May 16, 2019, 30 days after receiving the submission on April 16, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2800.
| 510(k) Number | K191000 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2019 |
| Decision Date | May 16, 2019 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DSH - Recorder, Magnetic Tape, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2800 |