K203231 is an FDA 510(k) clearance for the Switched Internal Paddles. This device is classified as a Dc-defibrillator, Low-energy, (including Paddles) (Class II - Special Controls, product code LDD).
Submitted by Philips North America, LLC (Bothell, US). The FDA issued a Cleared decision on January 11, 2021, 70 days after receiving the submission on November 2, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5300.
| 510(k) Number | K203231 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2020 |
| Decision Date | January 11, 2021 |
| Days to Decision | 70 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LDD - Dc-defibrillator, Low-energy, (including Paddles) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5300 |