Cleared Traditional

STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast

K150220 · Eb Neuro S.P.A. · Neurology
Aug 2015
Decision
201d
Days
Class 2
Risk

About This 510(k) Submission

K150220 is an FDA 510(k) clearance for the STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast, a Stimulator, Electrical, Evoked Response (Class II — Special Controls, product code GWF), submitted by Eb Neuro S.P.A. (Florence, IT). The FDA issued a Cleared decision on August 19, 2015, 201 days after receiving the submission on January 30, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1870.

Submission Details

510(k) Number K150220 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 2015
Decision Date August 19, 2015
Days to Decision 201 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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