K242018 is an FDA 510(k) clearance for the UbiqVue™ 2A Multi-parameter System (UX2550). This device is classified as a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II - Special Controls, product code DRG).
Submitted by Lifesignals, Inc. (Milpitas, US). The FDA issued a Cleared decision on November 12, 2024, 125 days after receiving the submission on July 10, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2910.
| 510(k) Number | K242018 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 2024 |
| Decision Date | November 12, 2024 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRG - Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2910 |