K893487 is an FDA 510(k) clearance for the LIFECARE 75 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 28, 1989, 85 days after receiving the submission on May 4, 1989.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K893487 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 1989 |
| Decision Date | July 28, 1989 |
| Days to Decision | 85 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 |