K832655 is an FDA 510(k) clearance for the ECOLYZER #200/COHB ANALYZER SYS. This device is classified as a Analyzer, Gas, Carbon-monoxide, Gaseous-phase (Class II - Special Controls, product code CCJ).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on September 26, 1983, 49 days after receiving the submission on August 8, 1983.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1430.
| 510(k) Number | K832655 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 1983 |
| Decision Date | September 26, 1983 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CCJ — Analyzer, Gas, Carbon-monoxide, Gaseous-phase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1430 |