The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda Tec 6 Continuous Flow Vaporizer.
Device ID | K913593 |
510k Number | K913593 |
Device Name: | OHMEDA TEC 6 CONTINUOUS FLOW VAPORIZER |
Classification | Vaporizer, Anesthesia, Non-heated |
Applicant | OHMEDA MEDICAL OHMEDA DRIVE, P.O. BOX 7550 Madison, WI 53707 -7550 |
Contact | Timothy M Davis |
Correspondent | Timothy M Davis 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 | 1991-08-13 |
Decision Date | 1992-10-06 |