K823404 is an FDA 510(k) clearance for the VOLUMERIC CONTROLLER. This device is classified as a Controller, Infusion, Intravascular, Electronic (Class II - Special Controls, product code LDR).
Submitted by Quest Medical, Inc. (Walker, US). The FDA issued a Cleared decision on December 22, 1982, 37 days after receiving the submission on November 15, 1982.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K823404 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 1982 |
| Decision Date | December 22, 1982 |
| Days to Decision | 37 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 |