K182503 is an FDA 510(k) clearance for the Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors. This device is classified as a Dc-defibrillator, Low-energy, (including Paddles) (Class II - Special Controls, product code LDD).
Submitted by Physio-Control, Inc. (Redmond, US). The FDA issued a Cleared decision on June 3, 2019, 264 days after receiving the submission on September 12, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5300.
| 510(k) Number | K182503 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2018 |
| Decision Date | June 03, 2019 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| 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 |