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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 K220976
Device Name Life Scope PT BSM-1700 Series Bedside Monitor
Applicant
Nihon Kohden Corporation
1-31-4 Nishiochiai, Shinjuki-Ku
Tokyo,  JP 161-8560
Applicant Contact Sandra Gadeyne
Correspondent
Nihon Koden America, Inc
15353 Barranca Parkway
Irvine,  CA  92618
Correspondent Contact Sunita Teekasingh
Regulation Number868.2775
Classification Product Code
KOI  
Subsequent Product Code
MHX  
Date Received04/04/2022
Decision Date 07/21/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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