Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09

About This 510(k) Submission

K210139 is an FDA 510(k) clearance for the Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09, a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on October 1, 2021, 255 days after receiving the submission on January 19, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.