510(k) K821989

NON-STETHO 7, UM-15TP by Hirata Sangyo Co. USA, Inc. — Product Code DXN

K821989 is an FDA 510(k) premarket notification submitted by Hirata Sangyo Co. USA, Inc. for the device "NON-STETHO 7, UM-15TP". The FDA issued a decision of Substantially Equivalent on October 18, 1982. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Hirata Sangyo Co. USA, Inc. has at least 7 other 510(k) clearances on record.