K212372 is an FDA 510(k) clearance for the Fitbit Irregular Rhythm Notifications. This device is classified as a Photoplethysmograph Analysis Software For Over-the-counter Use (Class II - Special Controls, product code QDB).
Submitted by Fitbit, Inc. (San Francisco, US). The FDA issued a Cleared decision on April 8, 2022, 252 days after receiving the submission on July 30, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2790. A Photoplethysmograph Analysis Software Device For Over-the-counter Use Analyzes Photoplethysmograph Data And Provides Information For Identifying Irregular Heart Rhythms. This Device Is Not Intended To Provide A Diagnosis..
| 510(k) Number | K212372 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 2021 |
| Decision Date | April 08, 2022 |
| Days to Decision | 252 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QDB - Photoplethysmograph Analysis Software For Over-the-counter Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2790 |
| Definition | A Photoplethysmograph Analysis Software Device For Over-the-counter Use Analyzes Photoplethysmograph Data And Provides Information For Identifying Irregular Heart Rhythms. This Device Is Not Intended To Provide A Diagnosis. |