MODIFIED MYOCARDIAL TEMPERATURE SENSOR
Device Facts
| Record ID | K874522 |
|---|---|
| Device Name | MODIFIED MYOCARDIAL TEMPERATURE SENSOR |
| Applicant | Mon-A-Therm, Inc. |
| Product Code | KRB · Cardiovascular |
| Decision Date | Jan 29, 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.