Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010197300

FEI Number

3010197300

Entity Name

MERIT CRO, Inc.

City/State/Country

Madison, WI, US

Establishment Address

6527 Normandy Ln, Suite 100, Madison, WI 53719, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MERIT CRO, Inc. (Owner Number: 10044019)

Owner / Operator Contact Address

6527 Normandy Ln, Suite 100, Madison, WI 53719, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K130453

PMA Number

N/A

All Registered Proprietary Names

EXCELSIOR Software

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NFJ	System, Image Management, Ophthalmic	Radiology	Class 2	892.2050	2013-04-18

Official Correspondent

Kymberly Larson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MERIT CRO, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010197300. Last updated year: 2026. Please use registration number 3010197300 when referencing this establishment in official correspondence.