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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, nerve, peripheral, electric
510(k) Number K201949
Device Name Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series
Applicant
Nihon Kohden Corporation
1-31-4 Nishiochiai, Shinjuki-Ku
Tokyo,  JP 161-8560
Applicant Contact Sandra Gadeyne
Correspondent
Nihon Kohden America, Inc.
15353 Barranca Parkway
Irvine,  CA  92618
Correspondent Contact Sunita Teekasingh
Regulation Number868.2775
Classification Product Code
KOI  
Date Received07/13/2020
Decision Date 05/02/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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