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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 K053234
Device Name PM-9000 EXPRESS PATIENT MONITOR
Original Applicant
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
55 northern blvd., suite 200
great neck,  NY  11021
Original Contact susan d goldstein-falk
Regulation Number870.2300
Classification Product Code
MWI  
Date Received11/18/2005
Decision Date 05/04/2006
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
Recalls CDRH Recalls
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