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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 K171292
Device Name A7 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   CCL  
KDP   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
Predetermined Change
Control Plan Authorized		 No
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