K811257 is an FDA 510(k) clearance for the CORNING 965 CARBON DIOXIDE ANALYZER. This device is classified as a Coulometric Method, Carbon-dioxide (Class II - Special Controls, product code CHS).
Submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on May 27, 1981, 22 days after receiving the submission on May 5, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1160.
| 510(k) Number | K811257 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 1981 |
| Decision Date | May 27, 1981 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CHS — Coulometric Method, Carbon-dioxide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1160 |