SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)
Device Facts
| Record ID | K883603 |
|---|---|
| Device Name | SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II) |
| Applicant | 3M Health Care, Sarns |
| Product Code | DWC · Cardiovascular |
| Decision Date | Nov 3, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4250 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger.
