The following data is part of a premarket notification filed by Datex-ohmeda Inc., A Division Of Instrumentarium C with the FDA for Engstrom Carestation, Engstrom Pro.
| Device ID | K093886 |
| 510k Number | K093886 |
| Device Name: | ENGSTROM CARESTATION, ENGSTROM PRO |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C 3030 OHMEDA DRIVE Madison, WI 53718 -6794 |
| Contact | Jim Raskob |
| Correspondent | Jim Raskob DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C 3030 OHMEDA DRIVE Madison, WI 53718 -6794 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-18 |
| Decision Date | 2010-05-03 |
| Summary: | summary |