510(k) K243891

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

March 26, 2025

Date Received

December 18, 2024

Clearance Type

Special

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Pediatric Autism Spectrum Disorder Diagnosis Aid

Device Class

Class II

Regulation Number

882.1491

Review Panel

NE

Submission Type

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.