K832470 is an FDA 510(k) clearance for the INFUSION PUMP. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Delta Medical Industries (Mchenry, US). The FDA issued a Cleared decision on February 28, 1984, 217 days after receiving the submission on July 26, 1983.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K832470 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 1983 |
| Decision Date | February 28, 1984 |
| Days to Decision | 217 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |