510(k) K812045

INFANT APNEA MONITOR MODEL 100 by Medix Medical Electronics (U.S.A.), Inc. — Product Code BZQ

K812045 is an FDA 510(k) premarket notification submitted by Medix Medical Electronics (U.S.A.), Inc. for the device "INFANT APNEA MONITOR MODEL 100". The FDA issued a decision of Substantially Equivalent on September 24, 1981. The device falls under product code BZQ (Monitor, Breathing Frequency), a Class II device regulated under 21 CFR 868.2375. Medix Medical Electronics (U.S.A.), Inc. has at least 10 other 510(k) clearances on record.