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FDA 510(k) Application Details - K162607
Device Classification Name
System,Network And Communication,Physiological Monitors
More FDA Info for this Device
510(K) Number
K162607
Device Name
System,Network And Communication,Physiological Monitors
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd
Mindray Building, Keji 12th Road South
Hi-tech Industrial Park, Nanshan
Shenzhen 518057 CN
Other 510(k) Applications for this Company
Contact
Yanhong Bai
Other 510(k) Applications for this Contact
Regulation Number
870.2300
More FDA Info for this Regulation Number
Classification Product Code
MSX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/19/2016
Decision Date
04/20/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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