510(k) K182503

Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors by Physio-Control, Inc. — Product Code LDD

K182503 is an FDA 510(k) premarket notification submitted by Physio-Control, Inc. for the device "Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors". The FDA issued a decision of Substantially Equivalent on June 3, 2019. The device falls under product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)), a Class II device regulated under 21 CFR 870.5300. Physio-Control, Inc. has at least 10 other 510(k) clearances on record.