510(k) K984618

BCI MINI-TORR PLUS, MODEL 6004 by Bci Intl., Inc. — Product Code DXN

K984618 is an FDA 510(k) premarket notification submitted by Bci Intl., Inc. for the device "BCI MINI-TORR PLUS, MODEL 6004". The FDA issued a decision of Substantially Equivalent on March 25, 1999. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Bci Intl., Inc. has at least 10 other 510(k) clearances on record.