The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Pressure Monitor Guards.
| Device ID | K851230 |
| 510k Number | K851230 |
| Device Name: | GAMBRO PRESSURE MONITOR GUARDS |
| Classification | Protector, Transducer, Dialysis |
| Applicant | GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Product Code | FIB |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-26 |
| Decision Date | 1985-04-09 |