K901588 is an FDA 510(k) clearance for the MINIMED(R) MODEL 506 EXTERNAL INSULIN PUMP. 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 July 2, 1990, 88 days after receiving the submission on April 5, 1990.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K901588 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 1990 |
| Decision Date | July 02, 1990 |
| Days to Decision | 88 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 |