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 |