510(k) K942546

CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER by Dynatech/Nevada, Inc. — Product Code DXN

K942546 is an FDA 510(k) premarket notification submitted by Dynatech/Nevada, Inc. for the device "CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER". The FDA issued a decision of Substantially Equivalent on January 27, 1995. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Dynatech/Nevada, Inc. has at least 5 other 510(k) clearances on record.