FDA 510(k)

MEP Monitor

K-Number: K162873 · 2017-03-31

Decision Date2017-03-31

Product CodeGWF

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MEP Monitor is a medical device manufactured by Tonica Elektronik A/S. It received FDA 510(k) clearance on 2017-03-31 under approval number K162873. 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 MEP Monitor?

MEP Monitor is a medical device that received FDA 510(k) clearance on 2017-03-31. It is manufactured by Tonica Elektronik A/S. The 510(k) number is K162873.

When was MEP Monitor approved by the FDA?

MEP Monitor received FDA 510(k) clearance on 2017-03-31, under approval number K162873.

What company makes MEP Monitor?

MEP Monitor is manufactured by Tonica Elektronik A/S.

What is the FDA product code for MEP Monitor?

The FDA product code for MEP Monitor is GWF.

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Related Devices (Code: GWF)

K160280MagPro R20Tonica Elektronik A/S K170677Neurovision Nerve Locator Monitor (Nerveana), EMGView SoftwareNeurovision Medical Product, Inc. 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.