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FDA 510(k)

Mag Vita TMS Therapy System w/Theta Burst Stimulation

K-Number: K173620 · 2018-08-14

ApplicantTonica Elektronik A/S
Decision Date2018-08-14
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Mag Vita TMS Therapy System w/Theta Burst Stimulation is a medical device manufactured by Tonica Elektronik A/S. It received FDA 510(k) clearance on 2018-08-14 under approval number K173620. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mag Vita TMS Therapy System w/Theta Burst Stimulation?

Mag Vita TMS Therapy System w/Theta Burst Stimulation is a medical device that received FDA 510(k) clearance on 2018-08-14. It is manufactured by Tonica Elektronik A/S. The 510(k) number is K173620.

When was Mag Vita TMS Therapy System w/Theta Burst Stimulation approved by the FDA?

Mag Vita TMS Therapy System w/Theta Burst Stimulation received FDA 510(k) clearance on 2018-08-14, under approval number K173620.

What company makes Mag Vita TMS Therapy System w/Theta Burst Stimulation?

Mag Vita TMS Therapy System w/Theta Burst Stimulation is manufactured by Tonica Elektronik A/S.

What is the FDA product code for Mag Vita TMS Therapy System w/Theta Burst Stimulation?

The FDA product code for Mag Vita TMS Therapy System w/Theta Burst Stimulation is OBP.

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Related PubMed Literature

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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

View all 13 devices →

Related Devices (Code: OBP)

K160309Neurosoft TMSTeleemg, LLC K161519NeuroStar TMS Therapy SystemNeuronetics, Inc. K160703NeuroStar TMS Therapy SystemNeuronetics, Inc. K173441Neurosoft TMS (also CloudTMS)Teleemg, LLC K171902Nexstim Navigated Brain Therapy (NBT) System 2Nexstim Plc K172667MagVita TMS Therapy w/MagPro R20Tonica Elektronik A/S

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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