FDA Registration
Active
🇮🇸 Iceland
DeepRESP
Reg #: 3007389703
·
FEI: 3007389703
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NOX MEDICAL
- Registration Number
- 3007389703
- FEI Number
- 3007389703
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Katrinartuni 2
- City
- Reykjavik
- Country
- IS
Regulatory Submissions
- 510(k) Number
- K241960
Owner / Operator
- Firm Name
- Nox Medical
- Operator Number
- 10027652
- Address
- Katrinartuni 2
- City
- Reykjavik
- State
- IS-55
- Postal Code
- IS-105
- Country
- IS
- Correspondent
- Robert Magnusson
US Agent
- Business Name
- Nox Health
- Contact Name
- Sigurjon Kristjansson
- Address
- 100 Kimball Place, Suite 100
- City
- Alpharetta
- State
- GA
- ZIP
- 30009
- Country
- US
- [email protected]
- Phone
- 888 5050280
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Automatic Event Detection Software For Polysomnograph With Electroencephalograph | OLZ | Class 2 | Neurology | No | 2025-06-04 |
Proprietary Names
DeepRESP
Establishment Types
Manufacture Medical Device