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FDA 510(k) Application Details - K000520
Device Classification Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
More FDA Info for this Device
510(K) Number
K000520
Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant
BREGAS AB
ULVSUNDAVAGEN 178B
BROMMA SE-16867 SE
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Contact
PAUL KRILL
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Regulation Number
868.1400
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Classification Product Code
CCK
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More FDA Info for this Product Code
Date Received
02/16/2000
Decision Date
05/16/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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