The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Ge Datex-ohmeda Avance.
| Device ID | K112722 |
| 510k Number | K112722 |
| Device Name: | GE DATEX-OHMEDA AVANCE |
| Classification | Gas-machine, Anesthesia |
| Applicant | DATEX-OHMEDA, INC. PO BOX 7550 Madison, WI 53707 -7550 |
| Contact | Jim Raskob |
| Correspondent | Jim Raskob DATEX-OHMEDA, INC. PO BOX 7550 Madison, WI 53707 -7550 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-19 |
| Decision Date | 2011-12-16 |
| Summary: | summary |