FDA 510(k) Application Details - K101034

Device Classification Name	System,Test,Breath Nitric Oxide   More FDA Info for this Device
510(K) Number	K101034
Device Name	System,Test,Breath Nitric Oxide
Applicant	AEROCRINE AB SUNDBYBERGSVAGEN 9 P.O. BOX 1024 SOLNA SE-17121 SE Other 510(k) Applications for this Company
Contact	JOHANNA KARLING 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	04/14/2010
Decision Date	09/02/2010
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