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
Oximeter, Tissue Saturation MUD

Proprietary Names

Clarifi Imaging System

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device