510(k) K823757

SURGITEK ENDOTRACHEAL TUBE, LASER RESIS by Medical Engineering Corp. — Product Code BTR

K823757 is an FDA 510(k) premarket notification submitted by Medical Engineering Corp. for the device "SURGITEK ENDOTRACHEAL TUBE, LASER RESIS". The FDA issued a decision of Substantially Equivalent on April 28, 1983. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Medical Engineering Corp. has at least 10 other 510(k) clearances on record.