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FDA 510(k) Application Details - K103046
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K103046
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
HOSMAN INTERNATIONAL CO., LTD
NO 58, FU CHIUN STREET
HSIN CHU CITY 30067 TW
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Contact
JEN KE-MIN
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
10/14/2010
Decision Date
01/10/2011
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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