JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE
Device Facts
| Record ID | K945720 |
|---|---|
| Device Name | JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE |
| Applicant | Jostra Bentley |
| Product Code | DWC · Cardiovascular |
| Decision Date | Mar 29, 1995 |
| 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.
