510(k) DEN230041
- Device
- Sleep Apnea Feature
- Applicant
- Samsung Electronics Co., Ltd.
- 510(k) number
- DEN230041
- Product code
- QZW
- Decision
- Unknown (DENG)
- Decision date
- 2024-02-06
- Date received
- 2023-05-31
- 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
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Hon Pak
- Address
- 129 Samsung-Ro, Yeoungton-Gu Suwon-Si KR
FDA Registration Numbers#
- 3017616353
- 3014343954
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QZW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240929 | Sleep Apnea Notification Feature (SANF) | Apple, Inc. | 2024-09-13 |