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FDA 510(k) Application Details - K063419
Device Classification Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
More FDA Info for this Device
510(K) Number
K063419
Device Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant
WELCH ALLYN PROTOCOL, INC.
8500 S.W. CREEKSIDE PLACE
BEAVERTON, OR 97008-7107 US
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JEFFREY WAGNER
Other 510(k) Applications for this Contact
Regulation Number
870.2300
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Classification Product Code
MWI
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More FDA Info for this Product Code
Date Received
11/13/2006
Decision Date
12/04/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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