K863204 is an FDA 510(k) clearance for the DEKA JR.. 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 September 3, 1986, 15 days after receiving the submission on August 19, 1986.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K863204 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 1986 |
| Decision Date | September 03, 1986 |
| Days to Decision | 15 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 |