GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION)
Device Facts
| Record ID | K921929 |
|---|---|
| Device Name | GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION) |
| Applicant | General Devices |
| Product Code | DXH · Cardiovascular |
| Decision Date | Sep 18, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2920 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.
