The following data is part of a premarket notification filed by Biomedical Sensors, Inc. with the FDA for Paratrend 7 Intravascular Blood Gas Monitoring System.
| Device ID | K953893 |
| 510k Number | K953893 |
| Device Name: | PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM |
| Classification | Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling |
| Applicant | BIOMEDICAL SENSORS, INC. SHORT ST. High Wycombe, Bucks, GB Hp11 2qh |
| Contact | Karima Hebri |
| Correspondent | Karima Hebri BIOMEDICAL SENSORS, INC. SHORT ST. High Wycombe, Bucks, GB Hp11 2qh |
| Product Code | CCC |
| CFR Regulation Number | 868.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-17 |
| Decision Date | 1997-11-04 |