K864517 is an FDA 510(k) clearance for the MODEL 504-S EXTERNAL INFUSION PUMP FOR DIABETICS. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Medtronic Minimed (Sylmar, US). The FDA issued a Cleared decision on December 12, 1986, 25 days after receiving the submission on November 17, 1986.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K864517 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 1986 |
| Decision Date | December 12, 1986 |
| Days to Decision | 25 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 |