FDA Registration
Active
🇺🇸 United States
WPO-10B
Reg #: 3010984687
·
FEI: 3010984687
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Cloud DX Inc.
- Registration Number
- 3010984687
- FEI Number
- 3010984687
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- #824 - 20 JAY STREET
- City
- Brooklyn
- State
- NY
- ZIP
- 11201
- Country
- US
Regulatory Submissions
- 510(k) Number
- K170965
Owner / Operator
- Firm Name
- CloudDX Inc.
- Operator Number
- 10048345
- Address
- 20 Jay St, Suite 834
- City
- Brooklyn
- State
- NY
- Postal Code
- 11201
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2019-11-28 |
Proprietary Names
WPO-10B
WPO-10
Wireless Pulse Oximeter
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device