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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 K190011
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, Hi-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, Hi-tech Industrial
Park, Nanshan
Shenzhen,  CN 518057
Correspondent Contact Yanhong Bai
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
DQA   DRT   DSI   DSK   DXN  
FLL   MLD  
Date Received01/03/2019
Decision Date 07/10/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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