The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda Modulus Cd Anesthesia System With C.v..
Device ID | K910929 |
510k Number | K910929 |
Device Name: | OHMEDA MODULUS CD ANESTHESIA SYSTEM WITH C.V. |
Classification | Detector And Alarm, Arrhythmia |
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 | DSI |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-05 |
Decision Date | 1992-03-19 |