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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 the device name listed in this FDA 510(k) record. The listed applicant is Soterix Medical, Inc.. It received FDA 510(k) clearance on 2021-08-13 under 510(k) 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. The listed applicant is Soterix Medical, Inc.. The 510(k) number is K192823.

When did MEGA-TMS receive FDA 510(k) clearance?

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

Who is the listed applicant for MEGA-TMS?

The FDA 510(k) record lists Soterix Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEGA-TMS?

The FDA product code for MEGA-TMS is GWF.

Other records listing Soterix Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251653SPRY TMS Therapy System (0550)K233751Milieve (YPS-301BD)K234080MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)K191422Neural NavigatorK170291IontoDC

Related Devices (Code: GWF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253301BraiN20® (BraiN20)Time IS Brain, S.L.K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.K243982Nicolet EDXNatus Neurology IncorporatedK243495Natus Ultrapro S100 (982A0594)Natus Neurology IncorporatedK242345Delphi StimulatorQuantalx NeuroscienceK234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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