K845042 is an FDA 510(k) clearance for the ABBOTT INPERSOL CYCLER 1000. This device is classified as a System, Peritoneal, Automatic Delivery (Class II - Special Controls, product code FKX).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 19, 1985, 81 days after receiving the submission on December 28, 1984.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K845042 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 1984 |
| Decision Date | March 19, 1985 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FKX — System, Peritoneal, Automatic Delivery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5630 |