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FDA 510(k) Application Details - K162234
Device Classification Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
More FDA Info for this Device
510(K) Number
K162234
Device Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant
GUANGDONG BIOLIGHT MEDITECH CO., LTD.
INNOVATION FIRST ROAD
TECHNOLOGY INNOVATION COAST
ZHUHAI, 519085 CN
Other 510(k) Applications for this Company
Contact
Jing Liang
Other 510(k) Applications for this Contact
Regulation Number
870.2300
More FDA Info for this Regulation Number
Classification Product Code
MWI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/09/2016
Decision Date
01/04/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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