THE EXPERT MODELS RTS 2000 AND RTS 2000H
Device Facts
| Record ID | K862947 |
|---|---|
| Device Name | THE EXPERT MODELS RTS 2000 AND RTS 2000H |
| Applicant | Ocg Technology, Inc. |
| Product Code | DSI · Cardiovascular |
| Decision Date | Nov 4, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1025 |
| Device Class | Class 2 |
Regulatory Classification
Identification
The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.
Special Controls
*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
