FDA Product Code
FDA Product Code QDB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2790
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K231173 | Irregular Rhythm Notification Feature (IRNF) | Apple, Inc. | 2023-07-21 | Traditional | PDF ↗ |
| K213971 | Atrial Fibrillation History Feature | Apple, Inc. | 2022-06-03 | Traditional | PDF ↗ |
| K212372 | Fitbit Irregular Rhythm Notifications | Fitbit, Inc. | 2022-04-08 | Traditional | PDF ↗ |
| K212516 | IRNF App | Apple, Inc. | 2021-10-22 | Traditional | PDF ↗ |
| DEN180042 | Irregular Rhythm Notification Feature | Apple, Inc. | 2018-09-11 | Direct | — |
Product code QDB · Class II · Cardiovascular. Data: openFDA.