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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 K142552
Device Name A7 Anesthesia System
Applicant
ShenZhen Mindray Bio-Medical Electronics Co., Ltd
Mindray Building, Keji 12th Road South
High-tech Industrial Park, Nanshan
Shenzhen,  CN 518057
Applicant Contact Tang Hao
Correspondent
ShenZhen Mindray Bio-Medical Electronics Co., Ltd
Mindray Building, Keji 12th Road South
High-tech Industrial Park, Nanshan
Shenzhen,  CN 518057
Correspondent Contact Tang Hao
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received09/10/2014
Decision Date 01/23/2015
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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