K994218 is an FDA 510(k) clearance for the EASY CARE AND TUBING SETS, a System, Peritoneal, Automatic Delivery (Class II — Special Controls, product code FKX), submitted by Medionics International, Inc. (Markham, Ontario, CA). The FDA issued a Cleared decision on February 10, 2000, 57 days after receiving the submission on December 15, 1999. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K994218 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 15, 1999 |
| Decision Date | February 10, 2000 |
| Days to Decision | 57 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FKX — System, Peritoneal, Automatic Delivery |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5630 |