K890112 is an FDA 510(k) clearance for the ENGSTROM ELIZA + CO2 ANALYZER. This device is classified as a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II - Special Controls, product code CCK).
Submitted by Gambro, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on March 15, 1989, 63 days after receiving the submission on January 11, 1989.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1400.
| 510(k) Number | K890112 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 11, 1989 |
| Decision Date | March 15, 1989 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CCK — Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1400 |