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FDA 510(k)

MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system

K-Number: K193006 · 2020-08-09

ApplicantTonica Elektronik A/S
Decision Date2020-08-09
Product CodeQCI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system is a medical device manufactured by Tonica Elektronik A/S. It received FDA 510(k) clearance on 2020-08-09 under approval number K193006. The device is classified under product code QCI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system?

MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system is a medical device that received FDA 510(k) clearance on 2020-08-09. It is manufactured by Tonica Elektronik A/S. The 510(k) number is K193006.

When was MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system approved by the FDA?

MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system received FDA 510(k) clearance on 2020-08-09, under approval number K193006.

What company makes MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system?

MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system is manufactured by Tonica Elektronik A/S.

What is the FDA product code for MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system?

The FDA product code for MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system is QCI.

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Other Devices by Tonica Elektronik A/S

K160280MagPro R20 K172667MagVita TMS Therapy w/MagPro R20 K171967MagVita TMS Therapy System K171481MagVita TMS Therapy System K170114MagVita TMS Therapy - w/MagPro R20 K162873MEP Monitor

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Related Devices (Code: QCI)

DEN170078Brainsway Deep Transcranial Magnetic Stimulation (DTMS) SystemBrainways , Ltd. K183303Brainsway Deep TMS SystemBrainsway , Ltd. K212289NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStarNeuronetics, Inc. K233742CloudTMS Edge for OCDTeleemg, LLC K231350OCD MT Cap (85-00397-000)Neuronetics K221129CloudTMS for OCDTeleemg, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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