The following data is part of a premarket notification filed by Ohmeda Anesthesia Systems Therapy Group with the FDA for Ohmeda 7800 Anesthesia Ventilator.
Device ID | K913791 |
510k Number | K913791 |
Device Name: | OHMEDA 7800 ANESTHESIA VENTILATOR |
Classification | Gas-machine, Anesthesia |
Applicant | OHMEDA ANESTHESIA SYSTEMS THERAPY GROUP P.O. BOX 7550 OHMEDA DRIVE Madison, WI 53707 |
Contact | Timothy M Davis |
Correspondent | Timothy M Davis 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 | 1991-08-23 |
Decision Date | 1993-04-08 |