NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A 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 Bedside Monitor, Bsm 9100a Series.

Pre-market Notification Details

Device IDK082785
510k NumberK082785
Device Name:NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch,  CA  92610 -1601
ContactJack Coggan
CorrespondentJack Coggan
NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch,  CA  92610 -1601
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-09-23
Decision Date2008-11-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04931921899403 K082785 000
00841983101816 K082785 000
00841983101823 K082785 000
00841983101830 K082785 000
00841983101847 K082785 000
00841983103391 K082785 000
00841983103414 K082785 000
04931921102831 K082785 000
04931921899373 K082785 000
04931921899380 K082785 000
04931921899397 K082785 000
00841983100543 K082785 000

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