510(k) K993268

MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT by Mallinckrodt Dar S.R.L. — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2000
Date Received
September 30, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5450
Review Panel
AN
Submission Type