The following data is part of a premarket notification filed by Seratronics, Inc. with the FDA for Fresenius Haemodialysis ;machine A1008.
| Device ID | K844641 |
| 510k Number | K844641 |
| Device Name: | FRESENIUS HAEMODIALYSIS ;MACHINE A1008 |
| Classification | System, Dialysate Delivery, Central Multiple Patient |
| 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 | FKQ |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-28 |
| Decision Date | 1985-02-14 |