510(k) K041778

REIZEN TALKING BLOOD PRESSURE MONITOR, MODEL #SF860T by Maxi-Aids, Inc. — Product Code DXN

K041778 is an FDA 510(k) premarket notification submitted by Maxi-Aids, Inc. for the device "REIZEN TALKING BLOOD PRESSURE MONITOR, MODEL #SF860T". The FDA issued a decision of Substantially Equivalent on August 31, 2004. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Maxi-Aids, Inc. has at least 1 other 510(k) clearance on record.