510(k) K954391

MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER by Bio-Tek Instruments, Inc. — Product Code DRL

K954391 is an FDA 510(k) premarket notification submitted by Bio-Tek Instruments, Inc. for the device "MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER". The FDA issued a decision of Substantially Equivalent on November 17, 1995. The device falls under product code DRL (Tester, Defibrillator), a Class II device regulated under 21 CFR 870.5325. Bio-Tek Instruments, Inc. has at least 10 other 510(k) clearances on record.