The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Pump Modules Pmo Lo-110-pmd 10-210.
| Device ID | K822071 |
| 510k Number | K822071 |
| Device Name: | PUMP MODULES PMO LO-110-PMD 10-210 |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Roller Type |
| Applicant | GAMBRO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DWB |
| CFR Regulation Number | 870.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-14 |
| Decision Date | 1982-08-24 |