FDA Registration
Active
🇺🇸 United States
Model 3100
Reg #: 2183646
·
FEI: 2183646
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
2
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
- K102350
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 | 2012-01-12 |
Proprietary Names
Model 3100
Model 8000A(X)-WO2
Model 8000A(X)-WO
Model 3150
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device