SKI 5000
Device Facts
| Record ID | K812646 |
|---|---|
| Device Name | SKI 5000 |
| Applicant | Smithkline Diagnostics, Inc. |
| Product Code | DXK · Cardiovascular |
| Decision Date | Nov 16, 1981 |
| 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.
