K946206 is an FDA 510(k) clearance for the CIBA CORNING 8-- SERIES CO-OXIMETER. This device is classified as a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL).
Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on January 30, 1995, 40 days after receiving the submission on December 21, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1120.
| 510(k) Number | K946206 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 1994 |
| Decision Date | January 30, 1995 |
| Days to Decision | 40 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CHL — Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1120 |