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FDA 510(k) Application Details - K110770
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
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510(K) Number
K110770
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
WISTRON CORPORATION
6TH FLOOR NO 127 WUGONG 2ND RD
WUGU TOWNSHIP
TAIPEI COUNTY 24888 TW
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Contact
TELING HSU
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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
03/18/2011
Decision Date
11/16/2011
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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