Product code QPF

Device name

Pediatric Autism Spectrum Disorder Diagnosis Aid

Medical specialty

Neurology

Device class

2

Regulation number

882.1491

Review panel

NE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

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.

Source

FDA openFDA device classification dataset