510(k) K840909

AUTOMATED NON-INVASIVE PRESSURE MODULE by Gould, Inc. — Product Code DXN

K840909 is an FDA 510(k) premarket notification submitted by Gould, Inc. for the device "AUTOMATED NON-INVASIVE PRESSURE MODULE". The FDA issued a decision of Substantially Equivalent on June 15, 1984. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Gould, Inc. has at least 10 other 510(k) clearances on record.