The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Umbilical Artery Oxygen Sensor.
Device ID | K875225 |
510k Number | K875225 |
Device Name: | UMBILICAL ARTERY OXYGEN SENSOR |
Classification | Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling |
Applicant | OHMEDA MEDICAL 2007 PAN AM CIRCLE Tampa, FL 33702 |
Contact | Jill Phillips |
Correspondent | Jill Phillips OHMEDA MEDICAL 2007 PAN AM CIRCLE Tampa, FL 33702 |
Product Code | CCE |
CFR Regulation Number | 868.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-22 |
Decision Date | 1988-03-04 |