MODEL 100 SPECTRAVIEW
Device Facts
| Record ID | K800655 |
|---|---|
| Device Name | MODEL 100 SPECTRAVIEW |
| Applicant | Edwards Laboratories |
| Product Code | DQC · Cardiovascular |
| Decision Date | Apr 16, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2390 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A phonocardiograph is a device used to amplify or condition the signal from a heart sound transducer. This device furnishes the excitation energy for the transducer and provides a visual or audible display of the heart sounds.
