K891013 is an FDA 510(k) clearance for the MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING. This device is classified as a Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling (Class II - Special Controls, product code CCC).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on August 2, 1989, 155 days after receiving the submission on February 28, 1989.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1150.
| 510(k) Number | K891013 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 1989 |
| Decision Date | August 02, 1989 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CCC — Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1150 |