510(k) K850070

HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2 by Healthcheck Corp. — Product Code DXN

K850070 is an FDA 510(k) premarket notification submitted by Healthcheck Corp. for the device "HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2". The FDA issued a decision of Substantially Equivalent on January 22, 1985. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Healthcheck Corp. has at least 8 other 510(k) clearances on record.