K911964 is an FDA 510(k) clearance for the MODIFIED PANCRETEC PROVIDER ONE INFUSION SYSTEM. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 2, 1991, 92 days after receiving the submission on May 2, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K911964 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 1991 |
| Decision Date | August 02, 1991 |
| Days to Decision | 92 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 |