510(k) K030417

DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES by Philips Medical Systems — Product Code LDD

K030417 is an FDA 510(k) premarket notification submitted by Philips Medical Systems for the device "DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES". The FDA issued a decision of Substantially Equivalent on May 9, 2003. The device falls under product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)), a Class II device regulated under 21 CFR 870.5300. Philips Medical Systems has at least 10 other 510(k) clearances on record.