FLOW-DIRECTED PEDIATRIC THERMODIL- CATH
Device Facts
| Record ID | K843410 |
|---|---|
| Device Name | FLOW-DIRECTED PEDIATRIC THERMODIL- CATH |
| Applicant | Andover Medical, Inc. |
| Product Code | KRB · Cardiovascular |
| Decision Date | Nov 20, 1984 |
| 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.
