510(k) K863494

NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20 by Advantage Medical Systems, Inc. — Product Code DRT

K863494 is an FDA 510(k) premarket notification submitted by Advantage Medical Systems, Inc. for the device "NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20". The FDA issued a decision of Substantially Equivalent on December 22, 1986. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Advantage Medical Systems, Inc. has at least 10 other 510(k) clearances on record.