510(k) K240929
- Device
- Sleep Apnea Notification Feature (SANF)
- Applicant
- Apple, Inc.
- 510(k) number
- K240929
- Product code
- QZW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-09-13
- Date received
- 2024-04-04
- Regulation
- 868.2378
- Classification name
- Over-The-Counter Device To Assess Risk Of Sleep Apnea
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Lynda Ikejimba
- Address
- One Apple Park Way Cupertino CA US 95014 95014
FDA Registration Numbers#
- 3017616353
- 3014343954
Source Documents#
Other 510(k) Records For Product Code QZW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN230041 | Sleep Apnea Feature | Samsung Electronics Co., Ltd. | 2024-02-06 |