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FDA 510(k) Application Details - K110299
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K110299
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
ZHU KENG INDUSTRIAL ZONE
PING SHAN, LONG GANG DISTRICT
SHENSHEN, GUANG DONG 518118 CN
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Contact
PATRICK CHOW
Other 510(k) Applications for this Contact
Regulation Number
870.1130
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Classification Product Code
DXN
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More FDA Info for this Product Code
Date Received
02/01/2011
Decision Date
03/21/2011
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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