The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Biospal 3000s.
| Device ID | K840811 |
| 510k Number | K840811 |
| Device Name: | BIOSPAL 3000S |
| Classification | System, Dialysate Delivery, Central Multiple Patient |
| Applicant | HOSPAL MEDICAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FKQ |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-21 |
| Decision Date | 1984-04-02 |