Cleared Traditional

MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)

K110410 · Nihon Kohden Corp. · Neurology
Aug 2011
Decision
171d
Days
Class 2
Risk

About This 510(k) Submission

K110410 is an FDA 510(k) clearance for the MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT), a Electrode, Cortical (Class II — Special Controls, product code GYC), submitted by Nihon Kohden Corp. (Foothill, US). The FDA issued a Cleared decision on August 4, 2011, 171 days after receiving the submission on February 14, 2011. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1310.

Submission Details

510(k) Number K110410 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2011
Decision Date August 04, 2011
Days to Decision 171 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GYC — Electrode, Cortical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1310

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