Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM

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 Life Scope Pt Bsm-1700 Series, Ay Series, Data Acquisition Unit, Life Scope Bsm 6000 Series Bedside Monitoring System, Nihon Kohden Csm-1901 Bedside Monitoring System.

Pre-market Notification Details

Device IDK213316
510k NumberK213316
Device Name:Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-10-04
Decision Date2021-12-29

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.