P.H.D. - PERSONAL HEART DEVICE MODEL 5258
Device Facts
| Record ID | K963904 |
|---|---|
| Device Name | P.H.D. - PERSONAL HEART DEVICE MODEL 5258 |
| Applicant | Heart Alert, Inc. |
| Product Code | DXH · Cardiovascular |
| Decision Date | May 15, 1997 |
| 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.
