K922670 is an FDA 510(k) clearance for the THE MINIMED MODEL 404-SP AND 504-S. 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 September 16, 1993, 521 days after receiving the submission on April 13, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K922670 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 1992 |
| Decision Date | September 16, 1993 |
| Days to Decision | 521 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |