K843285 is an FDA 510(k) clearance for the TRI-MED 610 CAPNOSTAT GAS ANALYZER. This device is classified as a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II - Special Controls, product code CCK).
Submitted by Tri-Med, Inc. (Redmond, US). The FDA issued a Cleared decision on November 13, 1984, 84 days after receiving the submission on August 21, 1984.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1400.
| 510(k) Number | K843285 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 1984 |
| Decision Date | November 13, 1984 |
| Days to Decision | 84 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 |