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FDA 510(k) Application Details - K093452
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K093452
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
ANDON HEALTH CO.,LTD
NO 31, CHANGJIANG ROAD
NANKAI DISTRICT
TIANJIN 300190 CN
Other 510(k) Applications for this Company
Contact
LIU YI
Other 510(k) Applications for this Contact
Regulation Number
870.1130
More FDA Info for this Regulation Number
Classification Product Code
DXN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/05/2009
Decision Date
12/23/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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