K140575 is an FDA 510(k) clearance for the ENGSTROM CARESTATION, ENGSTROM PRO. 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 February 3, 2015, 334 days after receiving the submission on March 6, 2014.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K140575 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2014 |
| Decision Date | February 03, 2015 |
| Days to Decision | 334 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 |