510(k) K903816

URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR by Respiratory Support Products, Inc. — Product Code EZK

K903816 is an FDA 510(k) premarket notification submitted by Respiratory Support Products, Inc. for the device "URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR". The FDA issued a decision of Substantially Equivalent (kit, denovo) on October 31, 1990. The device falls under product code EZK (Catheter, Retention Type), a Class II device regulated under 21 CFR 876.5980. Respiratory Support Products, Inc. has at least 10 other 510(k) clearances on record.