The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Tec 820, Tec 850.
| Device ID | K172702 |
| 510k Number | K172702 |
| Device Name: | Tec 820, Tec 850 |
| Classification | Vaporizer, Anesthesia, Non-heated |
| 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 | CAD |
| CFR Regulation Number | 868.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-07 |
| Decision Date | 2018-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682124751 | K172702 | 000 |
| 00840682124744 | K172702 | 000 |
| 00840682124737 | K172702 | 000 |
| 00840682124720 | K172702 | 000 |