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FDA 510(k) Application Details - K002544
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K002544
Device Name
Computer, Diagnostic, Programmable
Applicant
OXFORD INSTRUMENTS
MANOR WAY
OLD WOKING, SURREY GU22 9JU GB
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Contact
BARRY BRIGHT
Other 510(k) Applications for this Contact
Regulation Number
870.1425
More FDA Info for this Regulation Number
Classification Product Code
DQK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/17/2000
Decision Date
09/13/2000
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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