The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Automatic Peritoneal Dialysis Cycler System.
| Device ID | K850406 |
| 510k Number | K850406 |
| Device Name: | AUTOMATIC PERITONEAL DIALYSIS CYCLER SYSTEM |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Contact | Julia A Meyer |
| Correspondent | Julia A Meyer TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Product Code | FKX |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-04 |
| Decision Date | 1985-02-21 |