FDA Registration
Active
🇺🇸 United States
nView s1 with nav option
Reg #: 3016619943
·
FEI: 3016619943
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- NVIEW MEDICAL
- Registration Number
- 3016619943
- FEI Number
- 3016619943
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 550 W 900 S Ste C
- City
- Salt Lake City
- State
- UT
- ZIP
- 84101
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221344
Owner / Operator
- Firm Name
- nView medical
- Operator Number
- 10083398
- Address
- 2681 E Parleys Way, STE 107
- City
- Salt Lake City
- State
- UT
- Postal Code
- 84109
- Country
- US
- Correspondent
- Lisa Last
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2022-12-30 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2022-12-30 |
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2022-12-30 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2022-12-30 |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | Class 2 | Radiology | No | 2022-12-30 |
Proprietary Names
nView s1 with nav option
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device