The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Engstrom Carestation, Engstrom Pro.
| Device ID | K140575 |
| 510k Number | K140575 |
| Device Name: | ENGSTROM CARESTATION, ENGSTROM PRO |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | DATEX-OHMEDA, INC. 3030 OHMEDA DR. P.O. BOX 7550 Madison, WI 53718 |
| Contact | Trishia Dwyer |
| Correspondent | Trishia Dwyer DATEX-OHMEDA, INC. 3030 OHMEDA DR. P.O. BOX 7550 Madison, WI 53718 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-06 |
| Decision Date | 2015-02-03 |
| Summary: | summary |