ACCESSORY TO GENESIS III (GCFM)
Device Facts
| Record ID | K913209 |
|---|---|
| Device Name | ACCESSORY TO GENESIS III (GCFM) |
| Applicant | Biosound, Inc. |
| Product Code | DXK · Cardiovascular |
| Decision Date | May 15, 1992 |
| 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.
