The following data is part of a premarket notification filed by Optical Sensors, Inc. with the FDA for Sensicath Point-of-care Blood Gas Monitoring Syste.
| Device ID | K931185 |
| 510k Number | K931185 |
| Device Name: | SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE |
| Classification | Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling |
| Applicant | OPTICAL SENSORS, INC. 7615 GOLDEN TRIANGLE DR., SUITE C Eden Prairie, MN 55344 |
| Contact | Gervaise Wilhelm |
| Correspondent | Gervaise Wilhelm OPTICAL SENSORS, INC. 7615 GOLDEN TRIANGLE DR., SUITE C Eden Prairie, MN 55344 |
| Product Code | CCC |
| CFR Regulation Number | 868.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-09 |
| Decision Date | 1993-10-21 |