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FDA 510(k) Application Details - K032857
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
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510(K) Number
K032857
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
COLIN MEDICAL INSTRUMENTS CORP.
5850 FARINON DR.
SAN ANTONIO, TX 78249 US
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Contact
MARK RISON
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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
09/12/2003
Decision Date
02/04/2004
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
Y
Expedited Review
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