K852358 is an FDA 510(k) clearance for the SYRINGE INFUSION PUMP - AS 20 SERIES. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Baxter Healthcare Corp (Hooksett, US). The FDA issued a Cleared decision on July 5, 1985, 32 days after receiving the submission on June 3, 1985.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K852358 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 1985 |
| Decision Date | July 05, 1985 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |