K800570 is an FDA 510(k) clearance for the HEPARIN PUMP #7420. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on April 16, 1980, 33 days after receiving the submission on March 14, 1980.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K800570 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 1980 |
| Decision Date | April 16, 1980 |
| Days to Decision | 33 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 |