LIFE SCOPE EC, MODEL BSM-1102

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

NIHON KOHDEN AMERICA, INC.

The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Life Scope Ec, Model Bsm-1102.

Pre-market Notification Details

Device IDK000517
510k NumberK000517
Device Name:LIFE SCOPE EC, MODEL BSM-1102
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine,  CA  92612 -1601
ContactBonnie Bishop
CorrespondentBonnie Bishop
NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine,  CA  92612 -1601
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-16
Decision Date2000-08-31

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