FDA 510(k) Application Details - K974417

Device Classification Name	Ventilator, Continuous, Non-Life-Supporting   More FDA Info for this Device
510(K) Number	K974417
Device Name	Ventilator, Continuous, Non-Life-Supporting
Applicant	RESMED CORP. 10121 CAROLL CANYON RD. SAN DIEGO, CA 92131 US Other 510(k) Applications for this Company
Contact	SCOTT DUDEVOIR Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	MNS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/24/1997
Decision Date	06/24/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review