FDA Registration
Active
🇺🇸 United States
Clarifi Imaging System
Reg #: 3013436077
·
FEI: 3013436077
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- MODULATED IMAGING, INC.
- Registration Number
- 3013436077
- FEI Number
- 3013436077
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2755 Bristol St Ste 285
- City
- Costa Mesa
- State
- CA
- ZIP
- 92626
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181623
Owner / Operator
- Firm Name
- Modulated Imaging, Inc.
- Operator Number
- 10053786
- Address
- 2755 Bristol Street, Suite 285
- City
- Costa Mesa
- State
- CA
- Postal Code
- 92626
- Country
- US
- Correspondent
- David J Cuccia
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter, Tissue Saturation | MUD | Class 2 | Cardiovascular | No | 2018-08-28 |
Proprietary Names
Clarifi Imaging System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device