510(k) K944257

LIONHEART 3 MULTI-PARAMETER SIMULATOR by Bio-Tek Instruments, Inc. — Product Code DRT

K944257 is an FDA 510(k) premarket notification submitted by Bio-Tek Instruments, Inc. for the device "LIONHEART 3 MULTI-PARAMETER SIMULATOR". The FDA issued a decision of Substantially Equivalent on September 21, 1994. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Bio-Tek Instruments, Inc. has at least 10 other 510(k) clearances on record.