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FDA 510(k) Application Details - K081924
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
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510(K) Number
K081924
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
CALHEALTH INC
NO 58, FU-CHIN ST.
HSIN-CHU CITY 30067 CN
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Contact
Ke-Min Jen
Other 510(k) Applications for this Contact
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
07/07/2008
Decision Date
01/07/2009
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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