510(k) K993268

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

K993268 is an FDA 510(k) premarket notification submitted by Mallinckrodt Dar S.R.L. for the device "MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT". The FDA issued a decision of Substantially Equivalent on April 19, 2000. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450. Mallinckrodt Dar S.R.L. has at least 1 other 510(k) clearance on record.