The following data is part of a premarket notification filed by Optex Biomedical with the FDA for Optex Blood Gas Monitoring System.
| Device ID | K896311 |
| 510k Number | K896311 |
| Device Name: | OPTEX BLOOD GAS MONITORING SYSTEM |
| Classification | Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling |
| Applicant | OPTEX BIOMEDICAL 2202 TIMBERLOCH PLACE, SUITE 135 The Woodlands, TX 77380 |
| Contact | Jeff Kasoff |
| Correspondent | Jeff Kasoff OPTEX BIOMEDICAL 2202 TIMBERLOCH PLACE, SUITE 135 The Woodlands, TX 77380 |
| Product Code | CCE |
| CFR Regulation Number | 868.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-01 |
| Decision Date | 1990-01-03 |