510(k) K935788

BICORE SMARTCATH INTRATRACHEAL CATHETER by Bicore Monitoring Systems — Product Code MOD

K935788 is an FDA 510(k) premarket notification submitted by Bicore Monitoring Systems for the device "BICORE SMARTCATH INTRATRACHEAL CATHETER". The FDA issued a decision of Substantially Equivalent on July 3, 1995. The device falls under product code MOD (Accessory To Continuous Ventilator (Respirator)), a Class II device regulated under 21 CFR 868.5895. Bicore Monitoring Systems has at least 3 other 510(k) clearances on record.