The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda 6000 Multi-gas Monitor.
Device ID | K863959 |
510k Number | K863959 |
Device Name: | OHMEDA 6000 MULTI-GAS MONITOR |
Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
Applicant | OHMEDA MEDICAL OHMEDA DRIVE, P.O. BOX 7550 Madison, WI 53707 -7550 |
Contact | Raymond T Riddle |
Correspondent | Raymond T Riddle OHMEDA MEDICAL OHMEDA DRIVE, P.O. BOX 7550 Madison, WI 53707 -7550 |
Product Code | JJQ |
CFR Regulation Number | 862.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-10 |
Decision Date | 1987-01-12 |