510(k) K061918

FOLEY CATHETERS WITH TEMPERATURE PROBE by GE Healthcare — Product Code EYC

K061918 is an FDA 510(k) premarket notification submitted by GE Healthcare for the device "FOLEY CATHETERS WITH TEMPERATURE PROBE". The FDA issued a decision of Substantially Equivalent on August 18, 2006. The device falls under product code EYC (Catheter, Upper Urinary Tract), a Class II device regulated under 21 CFR 876.5130. GE Healthcare has at least 10 other 510(k) clearances on record.