K926450 is an FDA 510(k) clearance for the EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH. This device is classified as a Catheter, Oximeter, Fiber-optic (Class II - Special Controls, product code DQE).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on February 22, 1993, 60 days after receiving the submission on December 24, 1992.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1230.
| 510(k) Number | K926450 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 24, 1992 |
| Decision Date | February 22, 1993 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DQE — Catheter, Oximeter, Fiber-optic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1230 |