K240377 is an FDA 510(k) clearance for the LIFEPAK® ECG Cables. This device is classified as a Cable, Transducer And Electrode, Patient, (including Connector) (Class II - Special Controls, product code DSA).
Submitted by Stryker Physio-Control (Redmond, US). The FDA issued a Cleared decision on May 7, 2024, 90 days after receiving the submission on February 7, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2900.
| 510(k) Number | K240377 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 2024 |
| Decision Date | May 07, 2024 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSA — Cable, Transducer And Electrode, Patient, (including Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2900 |