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FDA 510(k) Application Details - K033030
Device Classification Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
More FDA Info for this Device
510(K) Number
K033030
Device Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant
WITT BIOMEDICAL CORP
305 NORTH DR.
MELBOURNE, FL 32934 US
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Contact
ELFRIEDE PAGAN
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
09/26/2003
Decision Date
02/24/2004
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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