K943310 is an FDA 510(k) clearance for the MODEL 6100 AMBULATORY INFUSION SYSTEM. This device is classified as a Pump, Infusion, Pca (Class II - Special Controls, product code MEA).
Submitted by Pharmacia Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on February 21, 1995, 225 days after receiving the submission on July 11, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K943310 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Third Party Review (ST) |
| Date Received | July 11, 1994 |
| Decision Date | February 21, 1995 |
| Days to Decision | 225 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | MEA — Pump, Infusion, Pca |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |