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FDA 510(k) Application Details - K122098
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K122098
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
ANDON HEALTH CO., LTD
No. 3 Jin Ping Street,Ya An Road,
NANKAI DISTRICT
TIANJIN 300190 CN
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Contact
YI LIU
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
07/16/2012
Decision Date
03/21/2013
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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