The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Ge Datex-ohmeda Engstrom Carestation.
| Device ID | K050597 |
| 510k Number | K050597 |
| Device Name: | GE DATEX-OHMEDA ENGSTROM CARESTATION |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | DATEX-OHMEDA, INC. PO BOX 7550 Madison, WI 53707 |
| Contact | Dan Kosednar |
| Correspondent | Dan Kosednar DATEX-OHMEDA, INC. PO BOX 7550 Madison, WI 53707 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-09 |
| Decision Date | 2005-03-25 |
| Summary: | summary |