K935659 is an FDA 510(k) clearance for the BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST. This device is classified as a System, Peritoneal, Automatic Delivery (Class II - Special Controls, product code FKX).
Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on July 7, 1994, 225 days after receiving the submission on November 24, 1993.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K935659 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 1993 |
| Decision Date | July 07, 1994 |
| Days to Decision | 225 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FKX — System, Peritoneal, Automatic Delivery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5630 |