FDA Registration
Active
🇰🇷 South Korea
Samsung Sleep Apnea Feature
Reg #: 3017616353
·
FEI: 3017616353
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Samsung Electronics Co., Ltd. Mobile eXperience Business
- Registration Number
- 3017616353
- FEI Number
- 3017616353
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 129, Samsung-ro, Yeongtong-gu
- City
- Suwon-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- DEN230041
Owner / Operator
- Firm Name
- Samsung Electronics Co., Ltd.
- Operator Number
- 10076996
- Address
- 129, Samsung-ro, Yeongtong-gu
- City
- Suwon-si
- State
- Gyeonggi
- Postal Code
- 16677
- Country
- KR
- Correspondent
- Richard Chon
US Agent
- Business Name
- Samsung Research America
- Contact Name
- Matthew Wiggins
- Address
- 665 CLYDE AVE
- City
- Mountain View
- State
- CA
- ZIP
- 94043
- Country
- US
- [email protected]
- Phone
- 650 7705804
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Over-The-Counter Device To Assess Risk Of Sleep Apnea | QZW | Class 2 | Anesthesiology | No | 2024-02-20 |
Proprietary Names
Samsung Sleep Apnea Feature
Establishment Types
Manufacture Medical Device