K920061 is an FDA 510(k) clearance for the HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEM. This device is classified as a Analyzer, Ion, Hydrogen-ion (ph), Blood-phase, Indwelling (Class II - Special Controls, product code CBZ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 30, 1992, 83 days after receiving the submission on January 7, 1992.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1170.
| 510(k) Number | K920061 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 07, 1992 |
| Decision Date | March 30, 1992 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CBZ — Analyzer, Ion, Hydrogen-ion (ph), Blood-phase, Indwelling |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1170 |