FDA 510(k) Application Details - K123683

Device Classification Name	System,Test,Breath Nitric Oxide   More FDA Info for this Device
510(K) Number	K123683
Device Name	System,Test,Breath Nitric Oxide
Applicant	AEROCRINE AB SUNDBYBERGSVAGEN 9 SOLNA 17173 SE Other 510(k) Applications for this Company
Contact	KATHLEEN RICKARD, MD Other 510(k) Applications for this Contact
Regulation Number	862.3080   More FDA Info for this Regulation Number
Classification Product Code	MXA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/30/2012
Decision Date	12/27/2012
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