BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)— 510(k) K160378

Name: FDA 510(k) clearance K160378
Creator: U.S. Food and Drug Administration
Published: 2017-08-25

Substantially Equivalent

Brh Medical , Ltd.

FDA 510(k) clearance K160378 for BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS), Substantially Equivalent on 2017-08-25. Applicant: Brh Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Brh Medical , Ltd.
Product code: Code IMI
Device class: Class 2
Regulation: 21 CFR 890.5300
Advisory panel: Physical Medicine
Date received: 2016-02-10
Decision date: 2017-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jerusalem, IL

Download summary PDF View on FDA.gov ↗

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