The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda Biox 3760 Pulse Oximeter.
Device ID | K874104 |
510k Number | K874104 |
Device Name: | OHMEDA BIOX 3760 PULSE OXIMETER |
Classification | Oximeter |
Applicant | OHMEDA MEDICAL 4765 WALNUT ST. Boulder, CO 80301 |
Contact | Neill Doertenbach |
Correspondent | Neill Doertenbach 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 | 1987-10-08 |
Decision Date | 1987-12-03 |