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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(with arrhythmia detection or alarms)
510(k) Number K112637
Model CGS9003
Device Name NETKONNECT REMOTE NETWORK EXTENSION
Original Applicant
NIHON KOHDEN
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foothill ranch,  CA  92610
Original Contact steve geerdes
Regulation Number870.1025
Classification Product Code
MHX  
Date Received09/09/2011
Decision Date 12/09/2011
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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