510(k) K782088

MONITOR, HEART RATE MODEL 105 by Roche Medical Electronics, Inc. — Product Code DRT

K782088 is an FDA 510(k) premarket notification submitted by Roche Medical Electronics, Inc. for the device "MONITOR, HEART RATE MODEL 105". The FDA issued a decision of Substantially Equivalent on January 4, 1979. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Roche Medical Electronics, Inc. has at least 10 other 510(k) clearances on record.