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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 K171311
Device Name A5 Anesthesia System
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Mindray Builday, Keji 12th Road South,
Hi-tech Industrial Park,
Shenzhen,  CN 518057
Applicant Contact Yanhong Bai
Correspondent
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Mindray Builday, Keji 12th Road South,
Hi-tech Industrial Park,
Shenzhen,  CN 518057
Correspondent Contact Yanhong Bai
Regulation Number868.5160
Classification Product Code
BSZ  
Subsequent Product Codes
CBQ   CBR   CBS   CCK   CCL  
NHO   NHP   NHQ  
Date Received05/02/2017
Decision Date 01/12/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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