Fitbit Irregular Rhythm Notifications
FDA 510(k) clearance K212372 · decided 2022-04-08
Clearance details
- K-number
- K212372
- Device name
- Fitbit Irregular Rhythm Notifications
- Applicant
- Fitbit, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-07-30
- Decision date
- 2022-04-08
- Days to decision
- 252 days
- Clearance type
- Traditional
- Product code
- QDB
- Device class
- 2
- Regulation number
- 870.2790
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Fitbit
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Irregular Rhythm Notification Feature (IRNF) (K231173) | Apple, Inc. | 2023-07-21 |
| Atrial Fibrillation History Feature (K213971) | Apple, Inc. | 2022-06-03 |
| IRNF App (K212516) | Apple, Inc. | 2021-10-22 |
| Irregular Rhythm Notification Feature (DEN180042) | Apple, Inc. | 2018-09-11 |
Recalls involving this device
No recalls on record reference this clearance.