FDA 510(k) Application Details - DEN030001

Device Classification Name	System,Test,Breath Nitric Oxide   More FDA Info for this Device
510(K) Number	DEN030001
Device Name	System,Test,Breath Nitric Oxide
Applicant	AEROCRINE AB 16787 BERNARDO CENTER DR. SUITE A-1 SAN DIEGO, CA 92128 US Other 510(k) Applications for this Company
Contact	SEAN M CURRY 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	03/18/2003
Decision Date	04/30/2003
Decision	DENG -
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review