Umbilical Artery Oxygen Sensor
FDA 510(k) K875225 · Ohmeda Medical
510(k) numberK875225
Submission
- Device name
- Umbilical Artery Oxygen Sensor
- Applicant
- Ohmeda Medical
Tampa, FL, US - Received
- December 22, 1987
- Decision date
- March 4, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CCE – Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1200
- Specialty
- Anesthesiology
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| K896311 | Optex Blood Gas Monitoring SystemCCE · Traditional | Optex Biomedical | 01/03/1990SE |
| K890624 | Tissue Oxygen Monitor System, Model IICCE · Traditional | Baxter Healthcare Corp | 12/22/1989SE |
| K895150 | Continucath 1000 Intravascular Oxygen MonitoringCCE · Traditional | Shiley, Inc. | 11/28/1989SE |
| K895149 | Neocath 1000 Umbilical Artery Oxygen Monitoring SyCCE · Traditional | Shiley, Inc. | 11/28/1989SE |
| K884063 | Bard Abg 100 Intravascular Oxygen Monitor SystemCCE · Traditional | C.R. Bard, Inc. | 12/16/1988SE |
| K872896 | Umbilical Artery Oxygen Probe Model UAP-100CCE · Traditional | American Bentley | 02/12/1988SE |
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Questions and answers
When was Umbilical Artery Oxygen Sensor cleared by the FDA?
Umbilical Artery Oxygen Sensor (K875225) received a 510(k) decision of Substantially Equivalent on March 4, 1988, 73 days after the submission was received.
What is the product code of K875225?
The FDA product code is CCE – Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling, a Class II (moderate risk) device regulated under 21 CFR 868.1200.