510(k) K944673

MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE by Regulatory & Marketing Services, Inc. — Product Code EZL

K944673 is an FDA 510(k) premarket notification submitted by Regulatory & Marketing Services, Inc. for the device "MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE". The FDA issued a decision of Substantially Equivalent on April 10, 1996. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Regulatory & Marketing Services, Inc. has at least 10 other 510(k) clearances on record.