Life Scope PT BSM-1700 Series Bedside Monitor

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 Bedside Monitor.

Pre-market Notification Details

Device IDK220976
510k NumberK220976
Device Name:Life Scope PT BSM-1700 Series Bedside Monitor
ClassificationStimulator, Nerve, Peripheral, Electric
Applicant Nihon Kohden Corporation 1-31-4 Nishiochiai, Shinjuki-Ku Tokyo,  JP 161-8560
ContactSandra Gadeyne
CorrespondentSunita Teekasingh
Nihon Koden America, Inc 15353 Barranca Parkway Irvine,  CA  92618
Product CodeKOI  
CFR Regulation Number868.2775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-04
Decision Date2022-07-21

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