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FDA 510(k), K203735, Brainsway Deep TMS System
FDA 510(k), K203735, Brainsway Deep TMS System
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510(K) Number: K203735
Device Name: Brainsway Deep TMS System
Manufacturer: Brainsway Ltd.
Device Classification Name: Transcranial Magnetic Stimulator
Regulation Number: 882.5805
Classification Product Code: OBP
Date Received: 12/21/2020
Decision Date: 04/23/2021
Regulation Medical Specialty: Neurology
Device Name: Brainsway Deep TMS System
Manufacturer: Brainsway Ltd.
Device Classification Name: Transcranial Magnetic Stimulator
Regulation Number: 882.5805
Classification Product Code: OBP
Date Received: 12/21/2020
Decision Date: 04/23/2021
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
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