FDA 510(k)

MagPro R20

K-Number: K160280 · 2016-05-16

Decision Date2016-05-16

Product CodeGWF

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MagPro R20 is a medical device manufactured by Tonica Elektronik A/S. It received FDA 510(k) clearance on 2016-05-16 under approval number K160280. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MagPro R20?

MagPro R20 is a medical device that received FDA 510(k) clearance on 2016-05-16. It is manufactured by Tonica Elektronik A/S. The 510(k) number is K160280.

When was MagPro R20 approved by the FDA?

MagPro R20 received FDA 510(k) clearance on 2016-05-16, under approval number K160280.

What company makes MagPro R20?

MagPro R20 is manufactured by Tonica Elektronik A/S.

What is the FDA product code for MagPro R20?

The FDA product code for MagPro R20 is GWF.

Other Devices by Tonica Elektronik A/S

K172667MagVita TMS Therapy w/MagPro R20 K171967MagVita TMS Therapy System K171481MagVita TMS Therapy System K170114MagVita TMS Therapy - w/MagPro R20 K162873MEP Monitor K173620Mag Vita TMS Therapy System w/Theta Burst Stimulation

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Related Devices (Code: GWF)

K170677Neurovision Nerve Locator Monitor (Nerveana), EMGView SoftwareNeurovision Medical Product, Inc. K162873MEP MonitorTonica Elektronik A/S K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. K182542The EPAD 2 SystemSafeop Surgical, Inc. K200759NIM Vital, Nerve Integrity MonitorMedtronic Xomed, Inc. K192823MEGA-TMSSoterix Medical, Inc.

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.