K041775 is an FDA 510(k) clearance for the GE DATEX-OHMEDA ENGSTROM CARESTATION. This device is classified as a Ventilator, Continuous, Facility Use (Class II - Special Controls, product code CBK).
Submitted by Datex-Ohmeda, Inc. (Madison, US). The FDA issued a Cleared decision on October 26, 2004, 117 days after receiving the submission on July 1, 2004.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K041775 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2004 |
| Decision Date | October 26, 2004 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBK — Ventilator, Continuous, Facility Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |