FDA 510(k) Applications for Medical Device Product Code "LDD"
(Dc-Defibrillator, Low-Energy, (Including Paddles))

FDA 510(k) Number Applicant Device Name Decision Date
K011461 ACCESS CARDIOSYSTEMS, INC. ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR 05/28/2002
K982896 ALEXANDER MFG. CO. ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9 10/21/1998
K103334 CARDIO MEDICAL PRODUCTS, INC. CARDIO MED 01/18/2011
K103159 CARDIO MEDICAL PRODUCTS, INC. CARDIO MED MODEL A102, H104, O101, P103, AND Z100 01/11/2011
K103651 CARDIO MEDICAL PRODUCTS, INC. CARDIOMED 10/04/2011
K964469 CARDIOTRONICS SYSTEMS, INC. 700-F SERIES STIMULATION ELECTRODES 12/11/1996
K103783 FIAB S.P.A. EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC 06/16/2011
K150349 FULL POWER AED Rapid Hair Removal Pads 07/14/2015
K081442 HEART SYNC LLC HEART SYNC PEDIATRIC, MODEL PED-100 09/24/2008
K962551 MARQUETTE ELECTRONICS, INC. CARDIOSERV S 11/19/1996
K012274 MEDTRONIC PHYSIO-CONTROL CORP. MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER 02/05/2002
K971194 NIHON KOHDEN AMERICA, INC. NIHON KOHDEN TEC-6100A CARDIOLIFE MINI DEFIBRILLATOR & ACCESSORIES 07/09/1997
K971436 NIHON KOHDEN AMERICA, INC. NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES 10/21/1997
K971355 NIHON KOHDEN AMERICA, INC. NIHON KOHDEN TEC-7531 CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES 07/15/1997
K030417 PHILIPS MEDICAL SYSTEMS DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES 05/09/2003
K203231 Philips North America LLC Switched Internal Paddles 01/11/2021
K182503 Physio-Control, Inc. Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors 06/03/2019
K200849 Remote Diagnostic Technologies, Ltd, a Philips Company Tempus LS - Manual 07/24/2020
K970481 SURVIVALINK CORP. V2 07/01/1997
K993205 TZ MEDICAL, INC. BOOKER BOX, MODEL PAD 5010 07/20/2000
K032691 ZOLL MEDICAL CORP. ZOLL AUTOCLAVABLE INTERNAL HANDLES 11/13/2003
K963781 ZOLL MEDICAL CORP. ZOLL AUTOCLAVABLE INTERNAL HANDLES 05/20/1997
K042302 ZOLL MEDICAL CORP. ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE 10/26/2004
K140502 ZOLL MEDICAL CORPORATION ZOLL E SERIES ALS 11/06/2014
K081574 ZOLL MEDICAL CORPORATION ZOLL R SERIES 09/18/2008
K100654 ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS ZOLL PROPAQ MD 07/29/2010
K102468 ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS ZOLL PROPAQ MD 09/30/2010


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