meddevicedb.com FDA Device Reference

Innovo

DEN170049 Class II Direct
Decision Date
2018-11-06
Sponsor / Applicant
Bio-Medical Research, Ltd.

Technical Specification

510(k) Submission ID DEN170049
Product Code QAJ
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.5330
Decision Date 2018-11-06
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

Innovo received FDA 510(k) clearance under submission number DEN170049, sponsored by Bio-Medical Research, Ltd.. The device was reviewed via the Direct premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2018-11-06.

Classification & Regulation

This clearance is catalogued under FDA product code QAJ and 21 CFR 876.5330, within the Gastroenterology, Urology review panel as a Class II device.