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FDA 510(k) Application Details - K080326
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K080326
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
ANDON HEALTH CO.,LTD
NO. 10 JINPING ROAD
YAAN ROAD NANKAI DISTRICT
TIAJIN 300190 CN
Other 510(k) Applications for this Company
Regulation Number
870.1130
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Classification Product Code
DXN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/06/2008
Decision Date
07/31/2008
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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