FDA 510(k) Application Details - K003075

Device Classification Name	Ventilator, Continuous, Minimal Ventilatory Support,Facility Use   More FDA Info for this Device
510(K) Number	K003075
Device Name	Ventilator, Continuous, Minimal Ventilatory Support,Facility Use
Applicant	MALLINCKRODT, INC. 675 MCDONNELL BLVD. BLDG. 10-2-N ST. LOUIS, MO 63134 US Other 510(k) Applications for this Company
Contact	ANTHONY MULLIN Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	MNT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/03/2000
Decision Date	12/11/2001
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