COGNOA, INC.

FDA Device Registration & Listing · Newport Beach, CA, US · Registration 3020832299

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
3020832299
FEI Number
3020832299
Entity Name
COGNOA, INC.
City/State/Country
Newport Beach, CA, US
Establishment Address
5000 Campus Dr, Newport Beach, CA 92660, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Cognoa, Inc. (Owner Number: 10083227)
Owner / Operator Contact Address
5000 Campus Drive, Newport Beach, CA 92660, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
DEN200069
PMA Number
N/A

All Registered Proprietary Names

Canvas Dx Canvas Dx

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QPF Pediatric Autism Spectrum Disorder Diagnosis Aid Neurology Class 2 882.1491 2025-05-29
QPF Pediatric Autism Spectrum Disorder Diagnosis Aid Neurology Class 2 882.1491 2021-11-03

Official Correspondent

Steve Partono

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cognoa, 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 3020832299. Last updated year: 2026. Please use registration number 3020832299 when referencing this establishment in official correspondence.
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