The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Aisys Cs2.
| Device ID | K170872 |
| 510k Number | K170872 |
| Device Name: | Aisys CS2 |
| Classification | Gas-machine, Anesthesia |
| Applicant | Datex-Ohmeda, Inc. 3030 Ohmeda Drive PO Box 7550 Madison, WI 53707 -7550 |
| Contact | Michelle Huettner |
| Correspondent | Monica Morrison 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 | 2017-03-23 |
| Decision Date | 2017-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682123990 | K170872 | 000 |
| 00840682123983 | K170872 | 000 |
| 00195278588128 | K170872 | 000 |