FDA Registration
Active
🇺🇸 United States
X-100SP
Reg #: 2183646
·
FEI: 2183646
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NONIN MEDICAL, INC.
- Registration Number
- 2183646
- FEI Number
- 2183646
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 13700 1ST AVE, NORTH
- City
- Plymouth
- State
- MN
- ZIP
- 55441
- Country
- US
Regulatory Submissions
- 510(k) Number
- K132402
Owner / Operator
- Firm Name
- NONIN MEDICAL, INC.
- Operator Number
- 2183646
- Address
- 13700 1ST AVE, NORTH, --
- City
- Plymouth
- State
- MN
- Postal Code
- 55441
- Country
- US
- Correspondent
- John Melquist
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2014-03-18 |
Proprietary Names
X-100SP
8100SS
X-100M
Equanox
X-100
SenSmart
X-100Hub
8100SM
8100SL
INT-100
Establishment Types
Manufacture Medical Device