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

Total pages: 1,192  
Fully redacted pages: 444  
Content pages: 748

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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