CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR
Device Facts
| Record ID | K864619 |
|---|---|
| Device Name | CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR |
| Applicant | Shiley, Inc. |
| Product Code | KRL · Cardiovascular |
| Decision Date | Feb 3, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4205 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cardiopulmonary bypass bubble detector is a device used to detect bubbles in the arterial return line of the cardiopulmonary bypass circuit.
