The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Bicarbonate Monitor Bcm 10-2.
| Device ID | K864083 |
| 510k Number | K864083 |
| Device Name: | GAMBRO BICARBONATE MONITOR BCM 10-2 |
| Classification | System, Dialysate Delivery, Single Patient |
| Applicant | GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Contact | Jeffrey Shideman,phd |
| Correspondent | Jeffrey Shideman,phd GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Product Code | FKP |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-20 |
| Decision Date | 1986-11-06 |