K171028 is an FDA 510(k) clearance for the CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories. 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 August 17, 2017, 134 days after receiving the submission on April 5, 2017.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1400.
| 510(k) Number | K171028 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2017 |
| Decision Date | August 17, 2017 |
| Days to Decision | 134 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 |