K895436 is an FDA 510(k) clearance for the MODIFIED MINIMED III INFUSION PUMP. 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 May 24, 1990, 289 days after receiving the submission on August 8, 1989.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K895436 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 1989 |
| Decision Date | May 24, 1990 |
| Days to Decision | 289 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 |