K242693 is an FDA 510(k) clearance for the DEKA Infusion System, DEKA Administration Set. This device is classified as a Controller, Infusion, Intravascular, Electronic (Class II - Special Controls, product code LDR).
Submitted by Deka Research and Development Corporation (Manchester, US). The FDA issued a Cleared decision on October 7, 2024, 28 days after receiving the submission on September 9, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K242693 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2024 |
| Decision Date | October 07, 2024 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LDR - Controller, Infusion, Intravascular, Electronic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |