FDA 510(k) Application Details - K092031

Device Classification Name	Apparatus, Gas-Scavenging   More FDA Info for this Device
510(K) Number	K092031
Device Name	Apparatus, Gas-Scavenging
Applicant	AXON MEDICAL, INC. 2645 SACKETT DR. PARK CITY, UT 84098 US Other 510(k) Applications for this Company
Contact	JOSEPH ORR Other 510(k) Applications for this Contact
Regulation Number	868.5430   More FDA Info for this Regulation Number
Classification Product Code	CBN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/06/2009
Decision Date	04/16/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review