meddevicedb.com FDA Device Reference

EEVA 2.0

DEN120015 Class II Post-NSE
Decision Date
2014-06-06
Sponsor / Applicant
Auxogyn, Inc.

Technical Specification

510(k) Submission ID DEN120015
Product Code PBH
Medical Specialty / Panel Obstetrics/Gynecology
Regulation Citation 21 CFR 884.6195
Decision Date 2014-06-06
Clearance Pathway Post-NSE

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

EEVA 2.0 received FDA 510(k) clearance under submission number DEN120015, sponsored by Auxogyn, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2014-06-06.

Classification & Regulation

This clearance is catalogued under FDA product code PBH and 21 CFR 884.6195, within the Obstetrics/Gynecology review panel as a Class II device.