K842080 is an FDA 510(k) clearance for the ABBOTT LIFECARE 1050 CONTROLLER. This device is classified as a Controller, Infusion, Intravascular, Electronic (Class II - Special Controls, product code LDR).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 18, 1984, 56 days after receiving the submission on May 23, 1984.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K842080 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 1984 |
| Decision Date | July 18, 1984 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | LDR — Controller, Infusion, Intravascular, Electronic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |