510(k) K210139

Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 by Edan Instruments, Inc. — Product Code DXN

K210139 is an FDA 510(k) premarket notification submitted by Edan Instruments, Inc. for the device "Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09". The FDA issued a decision of Substantially Equivalent on October 1, 2021. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Edan Instruments, Inc. has at least 10 other 510(k) clearances on record.