Data / Medical devices / United States / Cognivue, Inc.

Cognivue, Inc.: FDA-registered device maker in Victor, NY, United States, 1 510(k) clearance

Name: Cognivue, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Cognivue, Inc. is registered with the FDA (registration 3014389576) in Victor, NY, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 5, 2015. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3014389576
Address: 7911 Rae BLVD, Victor, NY, United States, 14564
Owner or operator: Cognivue (10057376)
Roles: Manufacturer, Specification developer
First device listed: March 27, 2018
Registered through: 2026
Brand names listed: Cognivue, Cognivue Clarity, Cognivue Clarity Model 2, Cognivue Thrive, Cognivue Thrive Model 2

Devices it lists

Device	Product code	Class	Role	Source
Computerized Cognitive Assessment Aid	PKQ	2	Manufacturer, Specification developer	accessdata.fda.gov
Computerized Cognitive Assessment Aid, Exempt	PTY	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 5, 2015	DEN130033	COGNIVUE	PKQ	Unknown	Cerebral Assessment Systems, Inc.	accessdata.fda.gov

Compare with other makers

Updated June 5, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.