Irregular Rhythm Notification Feature (IRNF)
FDA 510(k) clearance K231173 · decided 2023-07-21
Clearance details
- K-number
- K231173
- Device name
- Irregular Rhythm Notification Feature (IRNF)
- Applicant
- Apple, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-04-25
- Decision date
- 2023-07-21
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- QDB
- Device class
- 2
- Regulation number
- 870.2790
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Cupertino, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Atrial Fibrillation History Feature (K213971) | Apple, Inc. | 2022-06-03 |
| Fitbit Irregular Rhythm Notifications (K212372) | Fitbit, Inc. | 2022-04-08 |
| 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.