FDA 510(k) Application Details - K992133

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K992133
Device Name	Ventilator, Continuous, Facility Use
Applicant	NEWPORT MEDICAL INSTRUMENTS, INC. 760 WEST 16TH ST., BLDG. N COSTA MESA, CA 92627 US Other 510(k) Applications for this Company
Contact	ROBERT W DICK 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	06/23/1999
Decision Date	08/04/2000
Decision	ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review