510(k) K003075

KNIGHTSTAR 330 VENTILATOR by Mallinckrodt, Inc. — Product Code MNT

Clearance Details

Decision
ST ()
Decision Date
December 11, 2001
Date Received
October 3, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type