The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Dates-ohmeda Aestiva Smartvent Mri.
| Device ID | K993410 |
| 510k Number | K993410 |
| Device Name: | DATES-OHMEDA AESTIVA SMARTVENT MRI |
| Classification | Gas-machine, Anesthesia |
| Applicant | DATEX-OHMEDA, INC. OHMEDA DR. P.O. BOX 7550 Madison, WI 53707 -7550 |
| Contact | Daniel Kosednar |
| Correspondent | Daniel Kosednar DATEX-OHMEDA, INC. OHMEDA DR. P.O. 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 | 1999-10-12 |
| Decision Date | 2000-04-25 |
| Summary: | summary |