K860229 is an FDA 510(k) clearance for the MODEL 900 INFUSION PUMP. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on April 9, 1986, 77 days after receiving the submission on January 22, 1986.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K860229 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 1986 |
| Decision Date | April 09, 1986 |
| Days to Decision | 77 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 |