The following data is part of a premarket notification filed by Datex-ohmeda with the FDA for Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000.
| Device ID | K111116 |
| 510k Number | K111116 |
| Device Name: | ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | DATEX-OHMEDA PO BOX 7550 3030 OHMEDA DR Madison, WI 53707 |
| Contact | Monica Morrison |
| Correspondent | Monica Morrison DATEX-OHMEDA PO BOX 7550 3030 OHMEDA DR Madison, WI 53707 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-21 |
| Decision Date | 2011-09-09 |
| Summary: | summary |