The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Pump Console Csl.
| Device ID | K822068 |
| 510k Number | K822068 |
| Device Name: | GAMBRO PUMP CONSOLE CSL |
| Classification | Console, Heart-lung Machine, Cardiopulmonary Bypass |
| Applicant | GAMBRO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTQ |
| CFR Regulation Number | 870.4220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-14 |
| Decision Date | 1982-08-24 |