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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
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
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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