FDA 510(k) Application Details - K070259

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

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510(K) Number K070259
Device Name Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Applicant BEDFONT SCIENTIFIC LTD.
PO BOX 4341
CROFTON, MD 21114 US
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Contact E.J. Smith
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Regulation Number 868.1430

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Classification Product Code CCJ
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Date Received 01/26/2007
Decision Date 02/21/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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