The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Pressure Monitor Prm 10.
| Device ID | K822822 |
| 510k Number | K822822 |
| Device Name: | GAMBRO PRESSURE MONITOR PRM 10 |
| Classification | Gauge, Pressure, Coronary, Cardiopulmonary Bypass |
| Applicant | GAMBRO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXS |
| CFR Regulation Number | 870.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-20 |
| Decision Date | 1982-10-18 |