The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Engstrom Eliza Duo Co2 & O2 Analyz.
| Device ID | K840645 |
| 510k Number | K840645 |
| Device Name: | ENGSTROM ELIZA DUO CO2 & O2 ANALYZ |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | GAMBRO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-15 |
| Decision Date | 1984-04-05 |