Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)

K-Number: K234080 · 2024-03-25

ApplicantSoterix Medical, Inc.
Decision Date2024-03-25
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) 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 2024-03-25 under 510(k) number K234080. 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-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)?

MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) is a medical device that received FDA 510(k) clearance on 2024-03-25. The listed applicant is Soterix Medical, Inc.. The 510(k) number is K234080.

When did MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) receive FDA 510(k) clearance?

MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) received FDA 510(k) clearance on 2024-03-25, under 510(k) number K234080.

Who is the listed applicant for MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)?

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-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)?

The FDA product code for MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) 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)K192823MEGA-TMSK191422Neural 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

View on FDA Database →

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

↑