meddevicedb.com FDA Device Reference

EndeavorRx

DEN200026 Class II Direct
Decision Date
2020-06-15
Sponsor / Applicant
Akili Interactive Labs, Inc.

Technical Specification

510(k) Submission ID DEN200026
Product Code QFT
Medical Specialty / Panel Obstetrics/Gynecology
Regulation Citation 21 CFR 882.5803
Decision Date 2020-06-15
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

EndeavorRx received FDA 510(k) clearance under submission number DEN200026, sponsored by Akili Interactive Labs, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2020-06-15.

Classification & Regulation

This clearance is catalogued under FDA product code QFT and 21 CFR 882.5803, within the Obstetrics/Gynecology review panel as a Class II device.