K945942 is an FDA 510(k) clearance for the AUTO SYRINGE(R) AS50 INFUSION PUMP. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on July 10, 1995, 217 days after receiving the submission on December 5, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K945942 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 1994 |
| Decision Date | July 10, 1995 |
| Days to Decision | 217 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 |