510(k) K961972

MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR by Aequitron Medical, Inc. — Product Code BZQ

K961972 is an FDA 510(k) premarket notification submitted by Aequitron Medical, Inc. for the device "MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR". The FDA issued a decision of ST on April 18, 1997. The device falls under product code BZQ (Monitor, Breathing Frequency), a Class II device regulated under 21 CFR 868.2375. Aequitron Medical, Inc. has at least 10 other 510(k) clearances on record.