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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 K112877
Model C50, C60, C80
Device Name COMEN MULTI-PARAMETER PATIENT MONITOR
Original Applicant
GOLDWAY (US), INC.
2600 mission street
suite 100
san marino,  CA  91108
Original Contact jimmy wu
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
DPS   DQA   DXN   FLL  
Date Received09/30/2011
Decision Date 11/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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