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FDA 510(k) Application Details - K090027
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K090027
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
ZEN STRONG MEDICAL TECHNOLOGY CO., LTD
6F,NO.88 NING JIN ST.
NUANNUAN DISTRICT
KEELUNG CITY 20542 TW
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Contact
CHENG ROIE-SHENG
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
01/05/2009
Decision Date
02/02/2009
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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