Smart Cable NMT Module And Accessories, Life Scope BSM 3000 Series And Life Scope BSM 6000 Series

Stimulator, Nerve, Peripheral, Electric

Nihon Kohden Corporation

The following data is part of a premarket notification filed by Nihon Kohden Corporation with the FDA for Smart Cable Nmt Module And Accessories, Life Scope Bsm 3000 Series And Life Scope Bsm 6000 Series.

Pre-market Notification Details

Device IDK201949
510k NumberK201949
Device Name:Smart Cable NMT Module And Accessories, Life Scope BSM 3000 Series And Life Scope BSM 6000 Series
ClassificationStimulator, Nerve, Peripheral, Electric
Applicant Nihon Kohden Corporation 1-31-4 Nishiochiai, Shinjuki-Ku Tokyo,  JP 161-8560
ContactSandra Gadeyne
CorrespondentSunita Teekasingh
Nihon Kohden America, Inc. 15353 Barranca Parkway Irvine,  CA  92618
Product CodeKOI  
CFR Regulation Number868.2775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-13
Decision Date2021-05-02

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