MODULATED IMAGING, INC.

FDA Device Registration & Listing · Costa Mesa, CA, US · Registration 3013436077

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013436077
FEI Number
3013436077
Entity Name
MODULATED IMAGING, INC.
City/State/Country
Costa Mesa, CA, US
Establishment Address
2755 Bristol St Ste 285, Costa Mesa, CA 92626, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Modulated Imaging, Inc. (Owner Number: 10053786)
Owner / Operator Contact Address
2755 Bristol Street, Suite 285, Costa Mesa, CA 92626, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K181623
PMA Number
N/A

All Registered Proprietary Names

Clarifi Imaging System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2018-08-28

Official Correspondent

David Cuccia

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Modulated Imaging, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K201432 Masimo Corporation Masimo O3 Regional Oximeter System 2020-08-29
K211561 Covidien, LLC INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) 2021-12-05

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013436077. Last updated year: 2026. Please use registration number 3013436077 when referencing this establishment in official correspondence.
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