Sleep Apnea Feature
FDA 510(k) clearance DEN230041 · decided 2024-02-06
Clearance details
- K-number
- DEN230041
- Device name
- Sleep Apnea Feature
- Applicant
- Samsung Electronics Co., Ltd.
- Decision
- Unknown
- Date received
- 2023-05-31
- Decision date
- 2024-02-06
- Days to decision
- 251 days
- Clearance type
- Direct
- Product code
- QZW
- Device class
- 2
- Regulation number
- 868.2378
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Suwon-Si, KR
- 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 Notification Feature (SANF) (K240929) | Apple, Inc. | 2024-09-13 |
Recalls involving this device
No recalls on record reference this clearance.