GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN
Device Facts
| Record ID | K873032 |
|---|---|
| Device Name | GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN |
| Applicant | Biosound, Inc. |
| Product Code | DXK · Cardiovascular |
| Decision Date | Feb 18, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2330 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An echocardiograph is a device that uses ultrasonic energy to create images of cardiovascular structures. It includes phased arrays and two-dimensional scanners.
