Devices · Cognoa, Inc.

Cognoa ASD Diagnosis Aid

Cognoa, Inc. is listed for Cognoa ASD Diagnosis Aid (DEN200069). The FDA list gives June 2, 2021 as the date of the final decision. The lead panel is Neurology, and the database link on the FDA list is the De Novo pathway. openFDA describes product code QPF as “Pediatric Autism Spectrum Disorder Diagnosis Aid”: A pediatric Autism Spectrum Disorder diagnosis aid is a prescription device that is intended for use as an aid in the diagnosis of Autism Spectrum Disorder in pediatric patients. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200069

Official FDA database record

Date of final decision

June 2, 2021

Company on the FDA list

Cognoa, Inc.

Lead panel

Neurology

Primary product code

QPF

openFDA device name for the code

Pediatric Autism Spectrum Disorder Diagnosis Aid

Device class

2

Regulation number

882.1491

openFDA decision description

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned