The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda 7400 Anesthesia Ventilator.
Device ID | K864129 |
510k Number | K864129 |
Device Name: | OHMEDA 7400 ANESTHESIA VENTILATOR |
Classification | Ventilator, Continuous, Facility Use |
Applicant | OHMEDA MEDICAL OHMEDA DRIVE, P.O. BOX 7550 Madison, WI 53707 -7550 |
Contact | R. T Riddle |
Correspondent | R. T Riddle OHMEDA MEDICAL OHMEDA DRIVE, P.O. BOX 7550 Madison, WI 53707 -7550 |
Product Code | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-21 |
Decision Date | 1986-12-16 |