meddevicedb.com FDA Device Reference

Cognoa ASD Diagnosis Aid

DEN200069 Class II Direct
Decision Date
2021-06-02
Sponsor / Applicant
Cognoa, Inc.

Technical Specification

510(k) Submission ID DEN200069
Product Code QPF
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.1491
Decision Date 2021-06-02
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Cognoa ASD Diagnosis Aid received FDA 510(k) clearance under submission number DEN200069, sponsored by Cognoa, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2021-06-02.

Classification & Regulation

This clearance is catalogued under FDA product code QPF and 21 CFR 882.1491, within the Neurology review panel as a Class II device.