Product code LDD
- Device name
- Dc-Defibrillator, Low-Energy, (Including Paddles)
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.5300
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K203231 | Switched Internal Paddles | Philips North America, LLC | 2021-01-11 |
| K200849 | Tempus LS - Manual | Remote Diagnostic Technologies, Ltd. A Philips Company | 2020-07-24 |
| K182503 | Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors | Physio-Control, Inc. | 2019-06-03 |
| K150349 | Rapid Hair Removal Pads | Full Power Aed | 2015-07-14 |
| K140502 | ZOLL E SERIES ALS | ZOLL Medical Corporation | 2014-11-06 |
| K103651 | CARDIOMED | Cardio Medical Products, Inc. | 2011-10-04 |
| K103783 | EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC | Fiab Spa | 2011-06-16 |
| K103334 | CARDIO MED | Cardio Medical Products, Inc. | 2011-01-18 |
| K103159 | CARDIO MED MODEL A102, H104, O101, P103, AND Z100 | Cardio Medical Products, Inc. | 2011-01-11 |
| K102468 | ZOLL PROPAQ MD | Zoll Medical Corporation, World Wide Headquarters | 2010-09-30 |
| K100654 | ZOLL PROPAQ MD | Zoll Medical Corporation, World Wide Headquarters | 2010-07-29 |
| K081442 | HEART SYNC PEDIATRIC, MODEL PED-100 | Heart Sync, LLC | 2008-09-24 |
| K081574 | ZOLL R SERIES | ZOLL Medical Corporation | 2008-09-18 |
| K042302 | ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE | Zoll Medical Corp | 2004-10-26 |
| K032691 | ZOLL AUTOCLAVABLE INTERNAL HANDLES | Zoll Medical Corp | 2003-11-13 |
| K030417 | DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES | Philips Medical Systems | 2003-05-09 |
| K011461 | ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR | Access Cardiosystems, Inc. | 2002-05-28 |
| K012274 | MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER | Medtronic Physio-Control Corp. | 2002-02-05 |
| K993205 | BOOKER BOX, MODEL PAD 5010 | Tz Medical, Inc. | 2000-07-20 |
| K982896 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9 | Alexander Mfg. Co. | 1998-10-21 |
| K971436 | NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES | Nihon Kohden America, Inc. | 1997-10-21 |
| K971355 | NIHON KOHDEN TEC-7531 CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES | Nihon Kohden America, Inc. | 1997-07-15 |
| K971194 | NIHON KOHDEN TEC-6100A CARDIOLIFE MINI DEFIBRILLATOR & ACCESSORIES | Nihon Kohden America, Inc. | 1997-07-09 |
| K970481 | V2 | Survivalink Corp. | 1997-07-01 |
| K963781 | ZOLL AUTOCLAVABLE INTERNAL HANDLES | Zoll Medical Corp | 1997-05-20 |
| K964469 | 700-F SERIES STIMULATION ELECTRODES | Cardiotronics Systems, Inc. | 1996-12-11 |
| K962551 | CARDIOSERV S | Marquette Electronics, Inc. | 1996-11-19 |
| K951110 | CARDIO SERV | Hellige GmbH | 1995-09-15 |
| K952085 | DPD DEFIBRILLATOR | Medical Research Laboratories, Inc. | 1995-06-05 |
| K940842 | UNIPOWER RECHARGEABLE BATTERY PACK | Unipower Corp. | 1994-09-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10888277634954 | Medline | MEDLINE INDUSTRIES, INC. | 2021-10-22 |
| 10888277634930 | Medline | MEDLINE INDUSTRIES, INC. | 2021-10-22 |
| 10888277634947 | Medline | MEDLINE INDUSTRIES, INC. | 2021-09-16 |
| 07613365002737 | Tempus LS-MANUAL | Schiller AG | 2020-08-11 |
| 08054242441765 | NA | FIAB SPA | 2020-04-12 |
| 08054242446456 | NA | FIAB SPA | 2020-04-12 |
| 08054242446449 | NA | FIAB SPA | 2020-04-12 |
| 08054242446432 | NA | FIAB SPA | 2020-04-12 |
| 08054242446425 | NA | FIAB SPA | 2020-04-12 |
| 08054242444933 | NA | FIAB SPA | 2020-04-12 |
| 08054242441895 | NA | FIAB SPA | 2020-04-12 |
| 08054242441857 | NA | FIAB SPA | 2020-04-12 |
| 08054242441840 | NA | FIAB SPA | 2020-04-12 |
| 08054242441833 | NA | FIAB SPA | 2020-04-12 |
| 08054242441826 | NA | FIAB SPA | 2020-04-12 |
| 08054242441819 | NA | FIAB SPA | 2020-04-12 |
| 08054242441802 | NA | FIAB SPA | 2020-04-12 |
| 08054242441871 | NA | FIAB SPA | 2020-04-12 |
| 08054242441772 | NA | FIAB SPA | 2020-04-12 |
| 08054242441796 | NA | FIAB SPA | 2020-04-12 |
| 08054242441789 | NA | FIAB SPA | 2020-04-12 |
| 15060441915105 | VERMED | NISSHA MEDICAL TECHNOLOGIES LTD | 2018-01-11 |
| 15060441915198 | VERMED | NISSHA MEDICAL TECHNOLOGIES LTD | 2018-01-08 |
| 15060441915181 | VERMED | NISSHA MEDICAL TECHNOLOGIES LTD | 2018-01-08 |
| 15060441915174 | VERMED | NISSHA MEDICAL TECHNOLOGIES LTD | 2018-01-08 |
| 10813150020319 | Vermed DEFIB PADS | GRAPHIC CONTROLS ACQUISITION CORP | 2017-01-13 |
| 10813150020296 | Vermed DEFIB PADS | GRAPHIC CONTROLS ACQUISITION CORP | 2017-01-13 |
| 10813150020272 | Vermed DEFIB PADS | GRAPHIC CONTROLS ACQUISITION CORP | 2017-01-13 |
| 10813150020258 | Vermed DEFIB PADS | GRAPHIC CONTROLS ACQUISITION CORP | 2017-01-13 |
| 10813150020234 | Vermed DEFIB PADS | GRAPHIC CONTROLS ACQUISITION CORP | 2017-01-13 |