FDA 510(k) Application Details - K000962

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

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510(K) Number K000962
Device Name Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Applicant BEDFONT SCIENTIFIC LTD.
BEDFONT HOUSE
HOLYWELL LANE
UPCHURCH, KENT ME9 7HN GB
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Contact MARTIN FOXLEY
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Regulation Number 868.1430

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Classification Product Code CCJ
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Date Received 03/24/2000
Decision Date 04/20/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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