K823374 is an FDA 510(k) clearance for the OXYGEN MONITOR IL 408. This device is classified as a Analyzer, Gas, Oxygen, Gaseous-phase (Class II - Special Controls, product code CCL).
Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on December 9, 1982, 27 days after receiving the submission on November 12, 1982.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1720.
| 510(k) Number | K823374 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 1982 |
| Decision Date | December 09, 1982 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CCL — Analyzer, Gas, Oxygen, Gaseous-phase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1720 |