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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: BrainsWay Deep TMS System for Treatment of Major Depressive Disorder (MDD) (Model 102)
Classification Name: TRANSCRANIAL MAGNETIC STIMULATOR
Product Code: OBP
Device Class: 2
Regulation Number: 882.5805
Medical Specialty: Neurology
Registered Establishment Name: BRAINSWAY LTD.
Registered Establishment Number: 3010300912
Premarket Submission Number: K122288
Owner/Operator: Brainsway Ltd.
Owner/Operator Number: 10044527
Establishment Operations: Manufacturer
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