The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda Modulus Cd Anesthesia System.
Device ID | K894309 |
510k Number | K894309 |
Device Name: | OHMEDA MODULUS CD ANESTHESIA SYSTEM |
Classification | Gas-machine, Anesthesia |
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 | BSZ |
CFR Regulation Number | 868.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-07-14 |
Decision Date | 1989-10-06 |