The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Ge Datex-ohmeda Heliox Delivery System.
| Device ID | K041524 |
| 510k Number | K041524 |
| Device Name: | GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-08 |
| Decision Date | 2004-09-20 |
| Summary: | summary |