K830177 is an FDA 510(k) clearance for the HARVARD APPARATUS FAMILY OF FLUID INFUS. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 7, 1983, 20 days after receiving the submission on January 18, 1983.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K830177 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 1983 |
| Decision Date | February 07, 1983 |
| Days to Decision | 20 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 |