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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 a medical device manufactured by Soterix Medical, Inc.. It received FDA 510(k) clearance on 2024-03-25 under approval 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. It is manufactured by Soterix Medical, Inc.. The 510(k) number is K234080.

When was MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) approved by the FDA?

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

What company makes 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 manufactured by Soterix Medical, Inc..

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.

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Other Devices by Soterix Medical, Inc.

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Related Devices (Code: GWF)

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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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