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FDA 510(k) Application Details - K070259
Device Classification Name
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
868.1430
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Classification Product Code
CCJ
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More FDA Info for this Product Code
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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