FDA 510(k), K200957, Brainsway Deep TMS System

FDA 510(k), K200957, Brainsway Deep TMS System

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510(K) Number: K200957
Device Name: Brainsway Deep TMS System
Manufacturer: Brainsway Ltd.
Device Classification Name: Transcranial Magnetic Stimulation System For Smoking Cessation
Regulation Number: 882.5802
Classification Product Code: QMD
Date Received: 04/09/2020
Decision Date: 08/21/2020
Regulation Medical Specialty: Neurology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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