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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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