510(k) K926450

EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH by Baxter Healthcare Corp — Product Code DQE

K926450 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH". The FDA issued a decision of Substantially Equivalent on February 22, 1993. The device falls under product code DQE (Catheter, Oximeter, Fiber-Optic), a Class II device regulated under 21 CFR 870.1230. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.