The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda Tec 5 Vaporizer For Use With Sevoflurane.
| Device ID | K942091 |
| 510k Number | K942091 |
| Device Name: | OHMEDA TEC 5 VAPORIZER FOR USE WITH SEVOFLURANE |
| Classification | Vaporizer, Anesthesia, Non-heated |
| Applicant | OHMEDA MEDICAL OHMEDA DRIVE, P.O. BOX 7550 Madison, WI 53707 -7550 |
| Contact | Charles Morreale |
| Correspondent | Charles Morreale OHMEDA MEDICAL OHMEDA DRIVE, P.O. 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 | 1994-05-02 |
| Decision Date | 1995-03-30 |