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 |