The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Fresenius Variable Fill Monitor.
| Device ID | K921052 |
| 510k Number | K921052 |
| Device Name: | FRESENIUS VARIABLE FILL MONITOR |
| Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
| Applicant | FRESENIUS USA, INC. 4090 PIKE LN. Concord, CA 94520 |
| Contact | Tom Folden |
| Correspondent | Tom Folden FRESENIUS USA, INC. 4090 PIKE LN. Concord, CA 94520 |
| Product Code | KDJ |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-05 |
| Decision Date | 1993-02-25 |