The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Ge Detax-ohmeda Anesthesia Delivery Unit (adu).
| Device ID | K050676 |
| 510k Number | K050676 |
| Device Name: | GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU) |
| Classification | Gas-machine, Anesthesia |
| Applicant | DATEX-OHMEDA, INC. P.O. BOX 7550 Madison, WI 53707 |
| Contact | Dan Kosednar |
| Correspondent | Dan Kosednar DATEX-OHMEDA, INC. P.O. BOX 7550 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 | 2005-03-16 |
| Decision Date | 2005-04-12 |
| Summary: | summary |