The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Engstrom Eliza + Co2 Analyzer.
| Device ID | K890112 |
| 510k Number | K890112 |
| Device Name: | ENGSTROM ELIZA + CO2 ANALYZER |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| 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 | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-11 |
| Decision Date | 1989-03-15 |