K843254 is an FDA 510(k) clearance for the DK*300 VOLUMETRIC INFUSION CONTROLLER. This device is classified as a Controller, Infusion, Intravascular, Electronic (Class II - Special Controls, product code LDR).
Submitted by Deka Research & Development Corp. (Manchester, US). The FDA issued a Cleared decision on October 11, 1984, 52 days after receiving the submission on August 20, 1984.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K843254 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 1984 |
| Decision Date | October 11, 1984 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | - |
| Product Code | LDR - Controller, Infusion, Intravascular, Electronic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |