K921052 is an FDA 510(k) clearance for the FRESENIUS VARIABLE FILL MONITOR, a Set, Administration, For Peritoneal Dialysis, Disposable (Class II — Special Controls, product code KDJ), submitted by Fresenius USA, Inc. (Concord, US). The FDA issued a Cleared decision on February 25, 1993, 357 days after receiving the submission on March 5, 1992. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K921052 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 05, 1992 |
| Decision Date | February 25, 1993 |
| Days to Decision | 357 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KDJ — Set, Administration, For Peritoneal Dialysis, Disposable |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5630 |