The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Ge Datex-ohmeda Aestiva/5 Mri Anesthesia System.
| Device ID | K050055 |
| 510k Number | K050055 |
| Device Name: | GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM |
| 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 | 2005-01-11 |
| Decision Date | 2005-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682102339 | K050055 | 000 |