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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 Bldg., Keji 12th Rd. S.
High-Tech Industrial Park, Nanshan
Shenzhen,  CN 518057
Applicant Contact YANHONG BAI
Correspondent
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Mindray Bldg., Keji 12th Rd. S.
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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