LDD — Dc-Defibrillator, Low-Energy, (Including Paddles) Class II
FDA product code LDD covers "Dc-Defibrillator, Low-Energy, (Including Paddles)", a Class II medical device regulated under 21 CFR 870.5300. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LDD
- Device Class
- Class II
- Regulation Number
- 870.5300
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K203231 | philips north america | Switched Internal Paddles | January 11, 2021 |
| K200849 | remote diagnostic technologies, ltd. a philips | Tempus LS - Manual | July 24, 2020 |
| K182503 | physio-control | Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators | June 3, 2019 |
| K150349 | full power aed | Rapid Hair Removal Pads | July 14, 2015 |
| K140502 | zoll medical corporation | ZOLL E SERIES ALS | November 6, 2014 |
| K103651 | cardio medical products | CARDIOMED | October 4, 2011 |
| K103783 | fiab | EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDI | June 16, 2011 |
| K103334 | cardio medical products | CARDIO MED | January 18, 2011 |
| K103159 | cardio medical products | CARDIO MED MODEL A102, H104, O101, P103, AND Z100 | January 11, 2011 |
| K102468 | zoll medical corporation, world wide headquarters | ZOLL PROPAQ MD | September 30, 2010 |
| K100654 | zoll medical corporation, world wide headquarters | ZOLL PROPAQ MD | July 29, 2010 |
| K081442 | heart sync | HEART SYNC PEDIATRIC, MODEL PED-100 | September 24, 2008 |
| K081574 | zoll medical corporation | ZOLL R SERIES | September 18, 2008 |
| K042302 | zoll medical | ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTE | October 26, 2004 |
| K032691 | zoll medical | ZOLL AUTOCLAVABLE INTERNAL HANDLES | November 13, 2003 |
| K030417 | philips medical systems | DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE | May 9, 2003 |
| K011461 | access cardiosystems | ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR | May 28, 2002 |
| K012274 | medtronic physio-control | MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER | February 5, 2002 |
| K993205 | tz medical | BOOKER BOX, MODEL PAD 5010 | July 20, 2000 |
| K982896 | alexander mfg | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9 | October 21, 1998 |