510(k) K953999

DANTEC DA CAPO by Dantec Medical, Inc. — Product Code EXY

K953999 is an FDA 510(k) premarket notification submitted by Dantec Medical, Inc. for the device "DANTEC DA CAPO". The FDA issued a decision of Substantially Equivalent on November 21, 1995. The device falls under product code EXY (Uroflowmeter), a Class II device regulated under 21 CFR 876.1800. Dantec Medical, Inc. has at least 10 other 510(k) clearances on record.