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FDA 510(k) Application Details - K073265
Device Classification Name
System,Test,Breath Nitric Oxide
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510(K) Number
K073265
Device Name
System,Test,Breath Nitric Oxide
Applicant
APIERON, INC.
155 JEFFERSON DRIVE
MENLO PARK, CA 94025 US
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Contact
RICHARD LOTTI
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Regulation Number
862.3080
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Classification Product Code
MXA
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More FDA Info for this Product Code
Date Received
11/20/2007
Decision Date
03/14/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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