510(k) K882955

SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283 by Kontron Instruments, Inc. — Product Code DXN

K882955 is an FDA 510(k) premarket notification submitted by Kontron Instruments, Inc. for the device "SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283". The FDA issued a decision of Substantially Equivalent on January 26, 1990. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Kontron Instruments, Inc. has at least 10 other 510(k) clearances on record.