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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name oximeter
510(k) Number K052693
Device Name PM-50 PULSE OXIMETER
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 Number870.2700
Classification Product Code
DQA  
Date Received09/28/2005
Decision Date 03/30/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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