510(k) K880504

MCT MEDICAL BROWNE UROSCAN URODYNAMIC by Mct Medical, Inc. — Product Code EXY

K880504 is an FDA 510(k) premarket notification submitted by Mct Medical, Inc. for the device "MCT MEDICAL BROWNE UROSCAN URODYNAMIC". The FDA issued a decision of Substantially Equivalent on June 17, 1988. The device falls under product code EXY (Uroflowmeter), a Class II device regulated under 21 CFR 876.1800. Mct Medical, Inc. has at least 2 other 510(k) clearances on record.