FDA 510(k)

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

N.º K: K193006 · 2020-08-09

Fecha de decisión2020-08-09

Código de productoQCI

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

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

Preguntas frecuentes

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. The listed applicant is Tonica Elektronik A/S. The 510(k) number is K193006.

When did MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system receive FDA 510(k) clearance?

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

Who is the listed applicant for MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system?

The FDA 510(k) record lists Tonica Elektronik A/S as the applicant. This does not by itself establish the device manufacturer.

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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Otros registros que enlistan a Tonica Elektronik A/S como solicitante

K260189MagVenture Accelerated TMS (aTMS) Therapy System K251125MagVenture TMS Therapy System K251119MagVenture TMS Therapy System K252032T65 (9016E061-)K230014MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption K221544MagVenture TMS Atlas Neuro Navigation System

Ver todos los 14 dispositivos →

Dispositivos relacionados (Código: QCI)

K243459Ultimate rTMS for OCD (M-series)Brain Ultimate, Inc.K230657BTL-99-OCBTL Industries, Inc.K233742CloudTMS Edge for OCDTeleemg, LLC K231350OCD MT Cap (85-00397-000)Neuronetics K221129CloudTMS for OCDTeleemg, LLC K212289NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStarNeuronetics, Inc.

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.