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FDA 510(k) Application Details - K072131
Device Classification Name
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
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510(K) Number
K072131
Device Name
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Applicant
SPECTRUM MEDICAL LTD
HARRIER 4,METEOR BUSINESS PARK
CHELTENHAM ROAD EAST
GLOUCESTER, GLOUCESTERHSIRE GL2 9QL GB
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Contact
STEVE TURNER
Other 510(k) Applications for this Contact
Regulation Number
870.4330
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Classification Product Code
DRY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/02/2007
Decision Date
08/17/2007
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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