The following data is part of a premarket notification filed by Datex-ohmeda with the FDA for Ge Datex-ohmeda Avance Cs2.
| Device ID | K131945 |
| 510k Number | K131945 |
| Device Name: | GE DATEX-OHMEDA AVANCE CS2 |
| Classification | Gas-machine, Anesthesia |
| Applicant | DATEX-OHMEDA 3030 OHMEDA DRIVE, P.O. BOX 7550 Madison, WI 53707 -7550 |
| Contact | James P Raskob |
| Correspondent | James P Raskob DATEX-OHMEDA 3030 OHMEDA DRIVE, P.O. BOX 7550 Madison, WI 53707 -7550 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-27 |
| Decision Date | 2013-08-08 |
| Summary: | summary |