Cleared Traditional

MEGA-TMS

K192823 · Soterix Medical, Inc. · Neurology
Aug 2021
Decision
681d
Days
Class 2
Risk

About This 510(k) Submission

K192823 is an FDA 510(k) clearance for the MEGA-TMS, a Stimulator, Electrical, Evoked Response (Class II — Special Controls, product code GWF), submitted by Soterix Medical, Inc. (New York, US). The FDA issued a Cleared decision on August 13, 2021, 681 days after receiving the submission on October 2, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1870.

Submission Details

510(k) Number K192823 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 2019
Decision Date August 13, 2021
Days to Decision 681 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWF — Stimulator, Electrical, Evoked Response
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1870

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