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FDA 510(k)

MEGA-TMS

K-Number: K192823 · 2021-08-13

ApplicantSoterix Medical, Inc.
Decision Date2021-08-13
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MEGA-TMS is a medical device manufactured by Soterix Medical, Inc.. It received FDA 510(k) clearance on 2021-08-13 under approval number K192823. 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 MEGA-TMS?

MEGA-TMS is a medical device that received FDA 510(k) clearance on 2021-08-13. It is manufactured by Soterix Medical, Inc.. The 510(k) number is K192823.

When was MEGA-TMS approved by the FDA?

MEGA-TMS received FDA 510(k) clearance on 2021-08-13, under approval number K192823.

What company makes MEGA-TMS?

MEGA-TMS is manufactured by Soterix Medical, Inc..

What is the FDA product code for MEGA-TMS?

The FDA product code for MEGA-TMS is GWF.

Other Devices by Soterix Medical, Inc.

K170291IontoDC K191422Neural Navigator K233751Milieve (YPS-301BD) K234080MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) K251653SPRY TMS Therapy System (0550)

Related Devices (Code: GWF)

K160280MagPro R20Tonica Elektronik A/S 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.

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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