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FDA 510(k) Application Details - K181923
Device Classification Name
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
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510(K) Number
K181923
Device Name
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Applicant
Spectrum Medical Ltd
Harrier 4, Meteor Business Park, Cheltenham Road East
Gloucester GL2 9QL GB
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Contact
Colleen Powell
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Regulation Number
870.4330
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Classification Product Code
DRY
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Date Received
07/18/2018
Decision Date
08/17/2018
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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