K122129 - SPHYGMOCOR XCEL
(FDA 510(k) Clearance)

K122129 is an FDA 510(k) clearance for the SPHYGMOCOR XCEL, a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Atcor Medical (West Ryde Nsw, AU). The FDA issued a Cleared decision on November 16, 2012, 121 days after receiving the submission on July 18, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.