ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A

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 Anesthesia Monitor; Bedside Monitor, Series Bsm-5130a.

Pre-market Notification Details

Device IDK030105
510k NumberK030105
Device Name:ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch,  CA  92610 -1601
ContactSerrah Namini
CorrespondentSerrah Namini
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 Received2003-01-13
Decision Date2003-03-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04931921859735 K030105 000
00841983100161 K030105 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.