Optex Blood Gas Monitoring System
FDA 510(k) K896311 · Optex Biomedical
510(k) numberK896311
Submission
- Device name
- Optex Blood Gas Monitoring System
- Applicant
- Optex Biomedical
The Woodlands, TX, US - Received
- November 1, 1989
- Decision date
- January 3, 1990
- 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
Other 510(k)s with product code CCE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K935778 | Via 1-01 Infusion Pump/Blood Chemistry SystemCCE · Traditional | Via Medical Corp. | 12/05/1996SEKD |
| K912145 | System Athena-Product Enhancements, AnesthesiaCCE · Traditional | S & W Medico Teknik | 05/05/1992SE |
| K910453 | Tops Needle Tip Probe & PVC Tip ProbeCCE · Traditional | Baxter Healthcare Corp | 08/13/1991SE |
| K905397 | PB3200 Intra-Arterial Blood Gas Monitoring SystemCCE · Traditional | Puritan Bennett Corp. | 05/14/1991SE |
| 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 |
| K875225 | Umbilical Artery Oxygen SensorCCE · Traditional | Ohmeda Medical | 03/04/1988SE |
| K872896 | Umbilical Artery Oxygen Probe Model UAP-100CCE · Traditional | American Bentley | 02/12/1988SE |
Questions and answers
When was Optex Blood Gas Monitoring System cleared by the FDA?
Optex Blood Gas Monitoring System (K896311) received a 510(k) decision of Substantially Equivalent on January 3, 1990, 63 days after the submission was received.
What is the product code of K896311?
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.