meddevicedb.com FDA Device Reference

CEFALY

DEN120019 Class II Post-NSE
Decision Date
2014-03-11
Sponsor / Applicant
Stx-Med Sprl

Technical Specification

510(k) Submission ID DEN120019
Product Code PCC
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.5891
Decision Date 2014-03-11
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

CEFALY received FDA 510(k) clearance under submission number DEN120019, sponsored by Stx-Med Sprl. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2014-03-11.

Classification & Regulation

This clearance is catalogued under FDA product code PCC and 21 CFR 882.5891, within the Neurology review panel as a Class II device.