De Novo DEN200069

Device: Cognoa ASD Diagnosis Aid
Contact: sophie dessalle
De Novo number: DEN200069
Product code: QPF
Regulation: 882.1491
Classification name: pediatric autism spectrum disorder diagnosis aid
Decision: granted (DENG)
Decision date: 2021-06-02
Date received: 2020-11-03
Classification advisory: Neurology
Review advisory: Neurology
Type: Direct

Current FDA Classification#

Product code: QPF
Device name: Pediatric Autism Spectrum Disorder Diagnosis Aid
Medical specialty: Neurology
Device class: 2
Regulation: 882.1491
Implant: N
Life sustain/support: N