FDA 510(k) Application Details - K000520

Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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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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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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