ONGUARD 1000, CATALOG #043611-000 & 043611-001
Device Facts
| Record ID | K870976 |
|---|---|
| Device Name | ONGUARD 1000, CATALOG #043611-000 & 043611-001 |
| Applicant | Cobe Laboratories, Inc. |
| Product Code | DTQ · Cardiovascular |
| Decision Date | May 6, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4220 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.
