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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 K043348
Device Name MODIFICATION TO PM-8000 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 Received12/06/2004
Decision Date 01/06/2005
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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