K081842 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 October 3, 2008, 95 days after receiving the submission on June 30, 2008.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K081842 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2008 |
| Decision Date | October 03, 2008 |
| Days to Decision | 95 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 |