FDA 510(k) Application Details - K072816

Device Classification Name	System,Test,Breath Nitric Oxide   More FDA Info for this Device
510(K) Number	K072816
Device Name	System,Test,Breath Nitric Oxide
Applicant	AEROCRINE AB 801 PENNSYLVANIA AVE. WASHINGTON, DC 20004 US Other 510(k) Applications for this Company
Contact	JOEL SLOMOFF 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	10/02/2007
Decision Date	03/03/2008
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