Cleared Traditional

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

K234080 · Soterix Medical, Inc. · Neurology

Mar 2024

Decision

94d

Days

Class 2

Risk

About This 510(k) Submission

K234080 is an FDA 510(k) clearance for the MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S), a Stimulator, Electrical, Evoked Response (Class II — Special Controls, product code GWF), submitted by Soterix Medical, Inc. (Woodbridge, US). The FDA issued a Cleared decision on March 25, 2024, 94 days after receiving the submission on December 22, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1870.

Submission Details

510(k) Number	K234080 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 22, 2023
Decision Date	March 25, 2024
Days to Decision	94 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF