510(k) K261011
- Device
- Sleep Apnea Feature (v2.0)
- Applicant
- Samsung Electronics Co., Ltd.
- 510(k) number
- K261011
- Product code
- QZW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-07-20
- Date received
- 2026-03-26
- 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
- N
Applicant Contact#
- Contact
- Hon Pak
- Address
- 129 Samsung-Ro, Yeoungton-Gu Suwon-Si KR
FDA Registration Numbers#
- 3014343954
- 3017616353