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

FDA 510(k) K234080 · Soterix Medical, Inc.

Substantially Equivalent

510(k) numberK234080

Submission

Device name
MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)
Applicant
Soterix Medical, Inc.
Woodbridge, NJ, US
Received
December 22, 2023
Decision date
March 25, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GWF – Stimulator, Electrical, Evoked Response
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1870
Specialty
Neurology

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Questions and answers

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

MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) (K234080) received a 510(k) decision of Substantially Equivalent on March 25, 2024, 94 days after the submission was received.

What is the product code of K234080?

The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.