The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda 4700 Oxicap Monitor.
Device ID | K873199 |
510k Number | K873199 |
Device Name: | OHMEDA 4700 OXICAP MONITOR |
Classification | Oximeter |
Applicant | OHMEDA MEDICAL 4765 WALNUT ST. Boulder, CO 80301 |
Contact | Ken Kiyama |
Correspondent | Ken Kiyama OHMEDA MEDICAL 4765 WALNUT ST. Boulder, CO 80301 |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-13 |
Decision Date | 1988-02-02 |