meddevicedb.com FDA Device Reference

Nerivio Migra

DEN180059 Class II Direct
Decision Date
2019-05-20
Sponsor / Applicant
Theranica Bioelectronics , Ltd.

Technical Specification

510(k) Submission ID DEN180059
Product Code QGT
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.5899
Decision Date 2019-05-20
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

Nerivio Migra received FDA 510(k) clearance under submission number DEN180059, sponsored by Theranica Bioelectronics , Ltd.. The device was reviewed via the Direct premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2019-05-20.

Classification & Regulation

This clearance is catalogued under FDA product code QGT and 21 CFR 882.5899, within the Neurology review panel as a Class II device.