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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(with arrhythmia detection or alarms)
510(k) Number K152902
Device Name Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
Applicant
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
MINDRAY BUILDING, KEJI 12TH ROAD SOUTH,
HIGH-TECH INDUSTRIAL PARK, NANSHAN
shenzhen,  CN 518057
Applicant Contact yanhong bai
Correspondent
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
MINDRAY BUILDING, KEJI 12TH ROAD SOUTH,
HIGH-TECH INDUSTRIAL PARK, NANSHAN
shenzhen,  CN 518057
Correspondent Contact yanhong bai
Regulation Number870.1025
Classification Product Code
MHX  
Date Received10/01/2015
Decision Date 02/18/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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