THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM
Device Facts
| Record ID | K884318 |
|---|---|
| Device Name | THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM |
| Applicant | Abbott Laboratories |
| Product Code | KRB · Cardiovascular |
| Decision Date | Dec 13, 1988 |
| 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.
