Nerivio, FGD000075-4.7— 510(k) K203181

Name: FDA 510(k) clearance K203181
Creator: U.S. Food and Drug Administration
Published: 2021-01-22

Substantially Equivalent

Theranica Bioelectronics , Ltd.

FDA 510(k) clearance K203181 for Nerivio, FGD000075-4.7, Substantially Equivalent on 2021-01-22. Applicant: Theranica Bioelectronics , Ltd.. Device class: 2.

Clearance details

Applicant: Theranica Bioelectronics , Ltd.
Product code: Code QGT
Device class: Class 2
Regulation: 21 CFR 882.5899
Advisory panel: Neurology
Date received: 2020-10-26
Decision date: 2021-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Netanya, IL

Download summary PDF View on FDA.gov ↗

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