The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Datex-ohmeda Tec 7 Anesthesia Vaporizer (enflurane).
| Device ID | K031027 |
| 510k Number | K031027 |
| Device Name: | DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE) |
| Classification | Vaporizer, Anesthesia, Non-heated |
| Applicant | DATEX-OHMEDA, INC. OHMEDA DR. P.O. BOX 7550 Madison, WI 53707 -7550 |
| Contact | William E Exner |
| Correspondent | William E Exner 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 | Yes |
| Date Received | 2003-04-01 |
| Decision Date | 2003-06-26 |
| Summary: | summary |