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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K201957
Device Name A8, A9 Anesthesia System
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 Number868.5160
Classification Product Code
BSZ  
Subsequent Product Codes
CBQ   CBR   CBS   CCK   KDP  
NHO   NHP   NHQ  
Date Received07/14/2020
Decision Date 03/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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