The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Aestiva 7900, Aestiva Mri, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance Cs2, Aisys, Aisys Cs2.
| Device ID | K172045 |
| 510k Number | K172045 |
| Device Name: | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2 |
| Classification | Gas-machine, Anesthesia |
| Applicant | Datex-Ohmeda, Inc. 3030 Ohmeda Drive, PO Box 7550 Madison, WI 53707 -7550 |
| Contact | Trishia Mercier |
| Correspondent | Trishia Mercier Datex-Ohmeda, Inc. 3030 Ohmeda Drive, PO 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 | 2017-07-06 |
| Decision Date | 2017-11-03 |
| Summary: | summary |