HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER
Device Facts
| Record ID | K950004 |
|---|---|
| Device Name | HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER |
| Applicant | Aerotel, Ltd. |
| Product Code | DPS · Cardiovascular |
| Decision Date | Oct 24, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2340 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.
