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510(k) K160378

BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) by Brh Medical , Ltd. — Product Code IMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2017
Date Received
February 10, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5300
Review Panel
PM
Submission Type

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