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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 Bldg., Keji 12th Rd. S.
Hi-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.
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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