Switched Internal Paddles
FDA 510(k) K203231 · Philips North America, LLC
510(k) numberK203231
Submission
- Device name
- Switched Internal Paddles
- Applicant
- Philips North America, LLC
Bothell, WA, US - Received
- November 2, 2020
- Decision date
- January 11, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LDD – Dc-Defibrillator, Low-Energy, (Including Paddles)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5300
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code LDD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K200849 | Tempus LS - ManualLDD · Traditional | Remote Diagnostic Technologies, Ltd. A Philips… | 07/24/2020SE |
| K182503 | Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsLDD · Traditional | Physio-Control, Inc. | 06/03/2019SE |
| K150349 | Rapid Hair Removal PadsLDD · Traditional | Full Power Aed | 07/14/2015SE |
| K140502 | Zoll E Series AlsLDD · Traditional | ZOLL Medical Corporation | 11/06/2014SE |
| K103651 | CardiomedLDD · Traditional | Cardio Medical Products, Inc. | 10/04/2011SE |
| K103783 | Euro Defi Pads Adult; Euro Defi Pads Adult Radiotransparent: Euro Defi Pads PediatricLDD · Traditional | Fiab Spa | 06/16/2011SE |
| K103334 | Cardio MedLDD · Traditional | Cardio Medical Products, Inc. | 01/18/2011SE |
| K103159 | Cardio Med Model A102, H104, O101, P103, and Z100LDD · Traditional | Cardio Medical Products, Inc. | 01/11/2011SE |
| K102468 | Zoll Propaq MDLDD · Special | Zoll Medical Corporation, World Wide Headquarters | 09/30/2010SE |
| K100654 | Zoll Propaq MDLDD · Traditional | Zoll Medical Corporation, World Wide Headquarters | 07/29/2010SE |
Questions and answers
When was Switched Internal Paddles cleared by the FDA?
Switched Internal Paddles (K203231) received a 510(k) decision of Substantially Equivalent on January 11, 2021, 70 days after the submission was received.
What is the product code of K203231?
The FDA product code is LDD – Dc-Defibrillator, Low-Energy, (Including Paddles), a Class II (moderate risk) device regulated under 21 CFR 870.5300.