NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIES

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 Nihon Kohden Bsm-2300a Series Bedside Monitor And Accessories, Model Bsm-2300a Series.

Pre-market Notification Details

Device IDK011918
510k NumberK011918
Device Name:NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIES
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch,  CA  92610 -1601
ContactBonnie Bishop
CorrespondentBonnie Bishop
NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch,  CA  92610 -1601
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-06-20
Decision Date2001-09-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04931921859728 K011918 000
04931921101728 K011918 000
04931921101681 K011918 000
04931921101629 K011918 000
00841983103544 K011918 000
00841983103179 K011918 000
00841983100154 K011918 000

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