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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 K151954
Device Name A7 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 TANG HAO
Correspondent
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
MINDRAY BUILDING, KEJI 12TH ROAD SOUTH, HI-TECH INDUSTRIAL
PARK, NANSHAN
SHENZHEN,  CN 518057
Correspondent Contact TANG HAO
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received07/15/2015
Decision Date 10/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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