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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor,physiological,patient(without arrhythmia detection or alarms)
510(K) Number K032749
Device Name BEDSIDE MONITOR, MODEL OPV-1500
Applicant
NIHON KOHDEN AMERICA, INC.
90 icon st.
foothill ranch,  CA  92610 1601
Contact serrah namini
Regulation Number870.2300
Classification Product Code
MWI  
Date Received09/05/2003
Decision Date 09/16/2003
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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