CARDIOSCAN - TM BEING APPLIED FOR
Device Facts
| Record ID | K841263 |
|---|---|
| Device Name | CARDIOSCAN - TM BEING APPLIED FOR |
| Applicant | Interspec, Inc. |
| Product Code | DXK · Cardiovascular |
| Decision Date | Oct 19, 1984 |
| 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.