Panels › Cardiovascular › Product code QDB · Class 2
Photoplethysmograph Analysis Software For Over-The-Counter Use
Regulation 870.2790
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QDB
| Company | 510(k)s | Recalls |
|---|---|---|
| Apple, Inc. | 4 | 0 |
| Fitbit, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 21, 2023 | K231173 | Irregular Rhythm Notification Feature (IRNF) Apple, Inc. | QDB |
| Jun 3, 2022 | K213971 | Atrial Fibrillation History Feature Apple, Inc. | QDB |
| Apr 8, 2022 | K212372 | Fitbit Irregular Rhythm Notifications Fitbit, Inc. | QDB |
| Oct 22, 2021 | K212516 | IRNF App Apple, Inc. | QDB |
| Sep 11, 2018 | DEN180042 | Irregular Rhythm Notification Feature Apple, Inc. | QDB |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.