CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01
Device Facts
| Record ID | K001091 |
|---|---|
| Device Name | CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01 |
| Applicant | Next Millennium Software Solutions, Inc. |
| Product Code | DXH · Cardiovascular |
| Decision Date | Aug 10, 2000 |
| 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.
