510(k) K902114

CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR by Diemolding Corp. — Product Code BSK

K902114 is an FDA 510(k) premarket notification submitted by Diemolding Corp. for the device "CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR". The FDA issued a decision of Substantially Equivalent on July 18, 1990. The device falls under product code BSK (Cuff, Tracheal Tube, Inflatable), a Class II device regulated under 21 CFR 868.5750. Diemolding Corp. has at least 10 other 510(k) clearances on record.