510(k) K902785

MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON by Aequitron Medical, Inc. — Product Code BZQ

K902785 is an FDA 510(k) premarket notification submitted by Aequitron Medical, Inc. for the device "MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON". The FDA issued a decision of Substantially Equivalent on July 13, 1990. 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.