FDA 510(k), K201158, NeuroStar Advanced Therapy
FDA 510(k), K201158, NeuroStar Advanced Therapy
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510(K) Number: K201158
Device Name: NeuroStar Advanced Therapy
Manufacturer: Neuronetics, Inc.
Device Classification Name: Transcranial Magnetic Stimulator
Regulation Number: 882.5805
Classification Product Code: OBP
Date Received: 04/30/2020
Decision Date: 11/20/2020
Regulation Medical Specialty: Neurology
Device Name: NeuroStar Advanced Therapy
Manufacturer: Neuronetics, Inc.
Device Classification Name: Transcranial Magnetic Stimulator
Regulation Number: 882.5805
Classification Product Code: OBP
Date Received: 04/30/2020
Decision Date: 11/20/2020
Regulation Medical Specialty: Neurology
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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