Photoplethysmograph Analysis Software For Over-The-Counter Use
FDA product code QDB · Class II (moderate risk) · 21 CFR 870.2790 · Cardiovascular
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.
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231173 | Irregular Rhythm Notification Feature (IRNF)QDB · Traditional | Apple, Inc. | 07/21/2023SE |
| K213971 | Atrial Fibrillation History FeatureQDB · Traditional | Apple, Inc. | 06/03/2022SE |
| K212372 | Fitbit Irregular Rhythm NotificationsQDB · Traditional | Fitbit, Inc. | 04/08/2022SE |
| K212516 | IRNF AppQDB · Traditional | Apple, Inc. | 10/22/2021SE |