FDA 510(k) Application Details - K083617

Device Classification Name	System,Test,Breath Nitric Oxide   More FDA Info for this Device
510(K) Number	K083617
Device Name	System,Test,Breath Nitric Oxide
Applicant	APIERON, INC. 155 JEFFERSON DRIVE MENLO PARK, CA 94025 US Other 510(k) Applications for this Company
Contact	NINA PELED 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	12/08/2008
Decision Date	01/27/2009
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