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FDA 510(k) Application Details - K171292
Device Classification Name
Gas-Machine, Anesthesia
More FDA Info for this Device
510(K) Number
K171292
Device Name
Gas-Machine, Anesthesia
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Mindray Building, Keji 12th Road South ,
Hi-tech Industrial Park,
Shenzhen 518057 CN
Other 510(k) Applications for this Company
Contact
Yanhong Bai
Other 510(k) Applications for this Contact
Regulation Number
868.5160
More FDA Info for this Regulation Number
Classification Product Code
BSZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/02/2017
Decision Date
01/12/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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