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FDA 510(k) Application Details - K011352
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
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510(K) Number
K011352
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
ROSSMAX INTERNATIONAL LTD.
12F., NO.189, KANG CHIEN RD.
TAIPEI 114 TW
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Contact
MICHAEL YEH
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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
05/03/2001
Decision Date
07/20/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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