The following data is part of a premarket notification filed by Biomedical Sensors, Ltd. with the FDA for Paratrend 7 Satellite Intravascular Blood Gas Monitoring System.
| Device ID | K940188 |
| 510k Number | K940188 |
| Device Name: | PARATREND 7 SATELLITE INTRAVASCULAR BLOOD GAS MONITORING SYSTEM |
| Classification | Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling |
| Applicant | BIOMEDICAL SENSORS, LTD. SHORT STREET, HIGH WYCOMBE Bucks.hp11 2qh, England, GB |
| Contact | Jan Walters |
| Correspondent | Jan Walters BIOMEDICAL SENSORS, LTD. SHORT STREET, HIGH WYCOMBE Bucks.hp11 2qh, England, GB |
| Product Code | CCC |
| CFR Regulation Number | 868.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-13 |
| Decision Date | 1995-11-13 |