K960826 is an FDA 510(k) clearance for the CADD-PRIZM MODEL 6100 PUMP. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Sims Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on August 23, 1996, 176 days after receiving the submission on February 29, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K960826 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 29, 1996 |
| Decision Date | August 23, 1996 |
| Days to Decision | 176 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |