K150245 is an FDA 510(k) clearance for the CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX. This device is classified as a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II - Special Controls, product code CCK).
Submitted by GE Healthcare Finland Oy (Helsinki, FI). The FDA issued a Cleared decision on July 17, 2015, 165 days after receiving the submission on February 2, 2015.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1400.
| 510(k) Number | K150245 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 2015 |
| Decision Date | July 17, 2015 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CCK — Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1400 |