meddevicedb.com FDA Device Reference

NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR

DEN130022 Class II Direct
Decision Date
2013-12-13
Sponsor / Applicant
Eneura Therapeutics

Technical Specification

510(k) Submission ID DEN130022
Product Code OKP
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.5808
Decision Date 2013-12-13
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

NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR received FDA 510(k) clearance under submission number DEN130022, sponsored by Eneura Therapeutics. The device was reviewed via the Direct premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2013-12-13.

Classification & Regulation

This clearance is catalogued under FDA product code OKP and 21 CFR 882.5808, within the Neurology review panel as a Class II device.