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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 K113183
Model PMS8210A MODEL CODE 500
Device Name PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500
Original Applicant
SHANGHAI 3F ELECTRONICS CO LTD
77325 joyce way
echo,  OR  97826
Original Contact charilie mack
Regulation Number870.2300
Classification Product Code
MWI  
Date Received10/28/2011
Decision Date 02/09/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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