K802166 is an FDA 510(k) clearance for the MODEL AS* 7B AUTOSYRINGE INFUSION PUMP. This device is classified as a Monitor, Electric For Gravity Flow Infusion Systems (Class II - Special Controls, product code FLN).
Submitted by Baxter Healthcare Corp (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980, 65 days after receiving the submission on September 8, 1980.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2420.
| 510(k) Number | K802166 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 1980 |
| Decision Date | November 12, 1980 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FLN — Monitor, Electric For Gravity Flow Infusion Systems |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2420 |