The following data is part of a premarket notification filed by Datex-ohmeda Inc., A Division Of Instrumentarium C with the FDA for Aespire 7900, Aespire View.
| Device ID | K092864 |
| 510k Number | K092864 |
| Device Name: | AESPIRE 7900, AESPIRE VIEW |
| Classification | Gas-machine, Anesthesia |
| Applicant | DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C PO BOX 7550 3030 OHMEDA DRIVE Madison, WI 53707 -7550 |
| Contact | Adrienne Lenz |
| Correspondent | Adrienne Lenz DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C PO BOX 7550 3030 OHMEDA DRIVE 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 | 2009-09-17 |
| Decision Date | 2010-01-12 |
| Summary: | summary |