The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Datex-ohmeda Aestiva/5 With 7100 Ventilator.
| Device ID | K000706 |
| 510k Number | K000706 |
| Device Name: | DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR |
| Classification | Gas-machine, Anesthesia |
| Applicant | DATEX-OHMEDA, INC. OHMEDA DR. Madison, WI 53707 |
| Contact | Daniel Kosednar |
| Correspondent | Daniel Kosednar DATEX-OHMEDA, INC. OHMEDA DR. 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 | 2000-03-02 |
| Decision Date | 2000-05-11 |