The following data is part of a premarket notification filed by International Medical Products, Inc. with the FDA for Single-patient Automatic Dialysis Unit Mod. Dbb-22.
| Device ID | K863609 |
| 510k Number | K863609 |
| Device Name: | SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22 |
| Classification | System, Dialysate Delivery, Single Patient |
| Applicant | INTERNATIONAL MEDICAL PRODUCTS, INC. 4503 MOORLAND AVE. Minneapolis, MN 55435 |
| Contact | Jeffrey Shideman,phd |
| Correspondent | Jeffrey Shideman,phd INTERNATIONAL MEDICAL PRODUCTS, INC. 4503 MOORLAND AVE. Minneapolis, MN 55435 |
| Product Code | FKP |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-16 |
| Decision Date | 1987-02-25 |