510(k) K964697

AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION by Advance Medical Device, Inc. — Product Code DXN

K964697 is an FDA 510(k) premarket notification submitted by Advance Medical Device, Inc. for the device "AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION". The FDA issued a decision of Substantially Equivalent on February 11, 1997. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Advance Medical Device, Inc. has at least 4 other 510(k) clearances on record.