ECMO-TEMP (TM) BLOOD WARMING DEVICE
Device Facts
| Record ID | K873699 |
|---|---|
| Device Name | ECMO-TEMP (TM) BLOOD WARMING DEVICE |
| Applicant | Seabrook Medical Systems, Inc. |
| Product Code | DWC · Cardiovascular |
| Decision Date | Dec 22, 1987 |
| 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.
