meddevicedb.com FDA Device Reference

ZANZA-CLICK

DEN130019 Class II Direct
Decision Date
2014-11-07
Sponsor / Applicant
Tecnimed S.R.L.

Technical Specification

510(k) Submission ID DEN130019
Product Code OSG
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.5894
Decision Date 2014-11-07
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

ZANZA-CLICK received FDA 510(k) clearance under submission number DEN130019, sponsored by Tecnimed S.R.L.. The device was reviewed via the Direct premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2014-11-07.

Classification & Regulation

This clearance is catalogued under FDA product code OSG and 21 CFR 882.5894, within the Neurology review panel as a Class II device.