The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Ge Datex-ohmeda Avance.
| Device ID | K081844 |
| 510k Number | K081844 |
| Device Name: | GE DATEX-OHMEDA AVANCE |
| Classification | Gas-machine, Anesthesia |
| Applicant | DATEX-OHMEDA, INC. PO BOX 7550 3030 OHMEDA DR. Madison, WI 53707 |
| Contact | Adrienne Lenz |
| Correspondent | Adrienne Lenz DATEX-OHMEDA, INC. PO BOX 7550 3030 OHMEDA DR. Madison, WI 53707 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-30 |
| Decision Date | 2008-08-29 |
| Summary: | summary |