ROSETTA-LT/ROSETTA-RX
Device Facts
| Record ID | K002089 |
|---|---|
| Device Name | ROSETTA-LT/ROSETTA-RX |
| Applicant | General Devices |
| Product Code | DRG · Cardiovascular |
| Decision Date | Nov 21, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2910 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.
