FDA 510(k) Application Details - K972833

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K972833
Device Name	Ventilator, Continuous, Facility Use
Applicant	NEWPORT MEDICAL INSTRUMENTS, INC. 760 WEST 16TH ST., BLDG. M COSTA MESA, CA 92627 US Other 510(k) Applications for this Company
Contact	KARON MORELL Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	CBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/30/1997
Decision Date	09/23/1999
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