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FDA 510(k) Application Details - K014141
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
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510(K) Number
K014141
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
DIGIBIO TECHNOLOGY CORP.
6833 SAINT LAWRENCE ST.
PLANO, TX 75024 US
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Contact
ERIC LUO
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Regulation Number
870.1130
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Classification Product Code
DXN
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Date Received
12/17/2001
Decision Date
09/13/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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