Sleep Apnea Notification Feature (SANF)
FDA 510(k) clearance K240929 · decided 2024-09-13
Clearance details
- K-number
- K240929
- Device name
- Sleep Apnea Notification Feature (SANF)
- Applicant
- Apple, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-04-04
- Decision date
- 2024-09-13
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- QZW
- Device class
- 2
- Regulation number
- 868.2378
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- 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 |
|---|---|---|
| Sleep Apnea Feature (v2.0) (K261011) | Samsung Electronics Co., Ltd. | 2026-07-20 |
| Sleep Apnea Feature (DEN230041) | Samsung Electronics Co., Ltd. | 2024-02-06 |
Recalls involving this device
No recalls on record reference this clearance.