The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Datex-ohmeda D-tec Plus Anesthesia Vaporizer.
| Device ID | K002878 |
| 510k Number | K002878 |
| Device Name: | DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER |
| Classification | Vaporizer, Anesthesia, Non-heated |
| Applicant | DATEX-OHMEDA, INC. OHMEDA DR. P.O. BOX 7550 Madison, WI 53707 -7550 |
| Contact | Daniel Kosednar |
| Correspondent | Daniel Kosednar DATEX-OHMEDA, INC. OHMEDA DR. P.O. BOX 7550 Madison, WI 53707 -7550 |
| Product Code | CAD |
| CFR Regulation Number | 868.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-15 |
| Decision Date | 2000-09-21 |