FDA Registration
Active
🇺🇸 United States
SoftVue
Reg #: 3013759805
·
FEI: 3013759805
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DELPHINUS MEDICAL TECHNOLOGIES, INC.
- Registration Number
- 3013759805
- FEI Number
- 3013759805
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 45525 Grand River Ave, Ste 100
- City
- Novi
- State
- MI
- ZIP
- 48374
- Country
- US
Regulatory Submissions
- PMA Number
- P200040
Owner / Operator
- Firm Name
- Delphinus Medical Technologies, Inc.
- Operator Number
- 10085984
- Address
- 45525 Grand River Ave, Ste 100
- City
- Novi
- State
- MI
- Postal Code
- 48374
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Automated Breast Ultrasound | PAA | Class 3 | Unknown | No | 2022-10-07 |
Proprietary Names
SoftVue
Establishment Types
Manufacture Medical Device