K963948 is an FDA 510(k) clearance for the MINIMED INSULIN PUMP, MODEL 505. This device is classified as a Pump, Infusion, Insulin (Class II - Special Controls, product code LZG).
Submitted by Medtronic Minimed (Sylmar, US). The FDA issued a Cleared decision on April 8, 1997, 188 days after receiving the submission on October 2, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K963948 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Third Party Review (ST) |
| Date Received | October 02, 1996 |
| Decision Date | April 08, 1997 |
| Days to Decision | 188 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | LZG — Pump, Infusion, Insulin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |