The following data is part of a premarket notification filed by Ohmeda Anesthesia Systems Therapy Group with the FDA for Ohmeda Tec 6 (cfv) Continuous Flow Vaporizer, Nad.
| Device ID | K925580 |
| 510k Number | K925580 |
| Device Name: | OHMEDA TEC 6 (CFV) CONTINUOUS FLOW VAPORIZER, NAD |
| Classification | Gas-machine, Anesthesia |
| Applicant | OHMEDA ANESTHESIA SYSTEMS THERAPY GROUP P.O. BOX 7550 OHMEDA DRIVE Madison, WI 53707 |
| Contact | Graham B Lukey |
| Correspondent | Graham B Lukey OHMEDA ANESTHESIA SYSTEMS THERAPY GROUP P.O. BOX 7550 OHMEDA DRIVE Madison, WI 53707 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-04 |
| Decision Date | 1993-06-02 |