The following data is part of a premarket notification filed by Seratronics, Inc. with the FDA for Fresenius Hemodialysis Machine A1008 Bsm.
| Device ID | K855001 |
| 510k Number | K855001 |
| Device Name: | FRESENIUS HEMODIALYSIS MACHINE A1008 BSM |
| Classification | Station, Dialysis Control, Negative Pressure Type |
| Applicant | SERATRONICS, INC. 4090 PIKE LN. Concord, CA 94520 |
| Contact | Ben J Lipps |
| Correspondent | Ben J Lipps SERATRONICS, INC. 4090 PIKE LN. Concord, CA 94520 |
| Product Code | FLC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-13 |
| Decision Date | 1986-01-21 |