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FDA 510(k), K211389, Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation
FDA 510(k), K211389, Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation
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510(K) Number: K211389
Device Name: Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation
Manufacturer: Magstim Company Ltd.
Device Classification Name: Transcranial Magnetic Stimulator
Regulation Number: 882.5805
Classification Product Code: OBP
Date Received: 05/05/2021
Decision Date: 09/14/2021
Regulation Medical Specialty: Neurology
Device Name: Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation
Manufacturer: Magstim Company Ltd.
Device Classification Name: Transcranial Magnetic Stimulator
Regulation Number: 882.5805
Classification Product Code: OBP
Date Received: 05/05/2021
Decision Date: 09/14/2021
Regulation Medical Specialty: Neurology
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- 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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