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FDA 510(k), K193006, MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system
FDA 510(k), K193006, MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system
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510(K) Number: K193006
Device Name: MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system
Manufacturer: Tonica Elektronik A/S
Device Classification Name: Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
Regulation Number: 882.5802
Classification Product Code: QCI
Date Received: 10/28/2019
Decision Date: 08/09/2020
Regulation Medical Specialty: Neurology
Device Name: MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system
Manufacturer: Tonica Elektronik A/S
Device Classification Name: Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
Regulation Number: 882.5802
Classification Product Code: QCI
Date Received: 10/28/2019
Decision Date: 08/09/2020
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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