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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 K182821
Device Name Accutorr 7/VS-900/VS-900c Vital Signs Monitor
Applicant
Shenzhen Mindray Bio-medical Electronics Co., LTD.
Hi-tech Industrial Park, Nanshan
Shenzhen,  CN 518057
Applicant Contact Yanhong Bai
Correspondent
Shenzhen Mindray Bio-medical Electronics Co., LTD.
Hi-tech Industrial Park, Nanshan
Shenzhen,  CN 518057
Correspondent Contact Yanhong Bai
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
CCK   DQA   DXN   FLL  
Date Received10/04/2018
Decision Date 03/27/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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