SAFEWEDGE(TM) RELIEF VALVE DEVICE
Device Facts
| Record ID | K912172 |
|---|---|
| Device Name | SAFEWEDGE(TM) RELIEF VALVE DEVICE |
| Applicant | Sunscope Intl., Inc. |
| Product Code | KRB · Cardiovascular |
| Decision Date | Sep 27, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1915 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A thermodilution probe is a device that monitors cardiac output by use of thermodilution techniques; this device is commonly attached to a catheter that may have one or more probes.
