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FDA 510(k) Application Details - K150233
Device Classification Name
System,Test,Breath Nitric Oxide
More FDA Info for this Device
510(K) Number
K150233
Device Name
System,Test,Breath Nitric Oxide
Applicant
AEROCRINE AB
RASUNDAVAGEN 18, 8TH FLOOR
SOLNA SE-169 67 SE
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Contact
Kathleen Rickard
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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
02/02/2015
Decision Date
02/26/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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