510(k) K083347

IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS by Fluke Biomedical — Product Code DRL

K083347 is an FDA 510(k) premarket notification submitted by Fluke Biomedical for the device "IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS". The FDA issued a decision of Substantially Equivalent on December 24, 2008. The device falls under product code DRL (Tester, Defibrillator), a Class II device regulated under 21 CFR 870.5325. Fluke Biomedical has at least 5 other 510(k) clearances on record.