meddevicedb.com FDA Device Reference

EaseVRx

DEN210014 Class II Direct
Decision Date
2021-11-16
Sponsor / Applicant
Appliedvr, Inc.

Technical Specification

510(k) Submission ID DEN210014
Product Code QRA
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 890.5800
Decision Date 2021-11-16
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

EaseVRx received FDA 510(k) clearance under submission number DEN210014, sponsored by Appliedvr, 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 2021-11-16.

Classification & Regulation

This clearance is catalogued under FDA product code QRA and 21 CFR 890.5800, within the Neurology review panel as a Class II device.