FDA Registration
Active
🇺🇸 United States
HyperView
Reg #: 3013406514
·
FEI: 3013406514
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HYPERMED IMAGING, INC.
- Registration Number
- 3013406514
- FEI Number
- 3013406514
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 537 Steamboat RD, Ste 200
- City
- Greenwich
- State
- CT
- ZIP
- 06830
- Country
- US
Regulatory Submissions
- 510(k) Number
- K161237
Owner / Operator
- Firm Name
- HyperMed Imaging, Inc.
- Operator Number
- 10053984
- Address
- 537 Steamboat RD, Ste 200
- City
- Greenwich
- State
- CT
- Postal Code
- 06830
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter, Tissue Saturation | MUD | Class 2 | Cardiovascular | No | 2017-01-30 |
Proprietary Names
HyperView
Establishment Types
Repack or Relabel Medical Device