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FDA 510(k) Application Details - K122482
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K122482
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.
NO. 1 FANGHUA STREET
HI-TECH ZONE
CHENGDU 610041 CN
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Contact
LEO WANG
Other 510(k) Applications for this Contact
Regulation Number
870.1130
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Classification Product Code
DXN
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More FDA Info for this Product Code
Date Received
08/14/2012
Decision Date
10/22/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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