K240162 is an FDA 510(k) clearance for the LIFEPAK® 35 AC Power Adapter (41335-000001). This device is classified as a Auxiliary Power Supply (ac Or Dc) For Low-energy Dc-defibrillator (Class II - Special Controls, product code MPD).
Submitted by Stryker Physio-Control (Redmond, US). The FDA issued a Cleared decision on April 19, 2024, 88 days after receiving the submission on January 22, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5300.
| 510(k) Number | K240162 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 2024 |
| Decision Date | April 19, 2024 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MPD — Auxiliary Power Supply (ac Or Dc) For Low-energy Dc-defibrillator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5300 |