510(k) K980756

COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE by Ge Medical Systems Information Technologies — Product Code LKD

K980756 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Information Technologies for the device "COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE". The FDA issued a decision of Substantially Equivalent on November 5, 1998. The device falls under product code LKD (Monitor, Carbon-Dioxide, Cutaneous), a Class II device regulated under 21 CFR 868.2480. Ge Medical Systems Information Technologies has at least 10 other 510(k) clearances on record.