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FDA 510(k) Application Details - K053112
Device Classification Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
More FDA Info for this Device
510(K) Number
K053112
Device Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant
OXFORD BIOSIGNALS LIMITED
555 13TH ST. NW
WASHINGTON, DC 20004 US
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Contact
HOWARD M HOLSTEIN
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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
11/04/2005
Decision Date
01/31/2006
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
N
Expedited Review
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