QYW · Hospital Cardiac Telemetry
Cardiovascular · 21 CFR 870.1025 · Class 2
Overview
| Product Code | QYW |
|---|---|
| Device Name | Hospital Cardiac Telemetry |
| Regulation | 21 CFR 870.1025 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| Life-Sustaining | Yes |
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.
Classification Rationale
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.
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K133973 | TEMPUS PRO WITH ENHANCED FEATURES | Remote Diagnostic Technologies , Ltd. | Aug 14, 2014 | SESE |
| K934913 | HEARTRAC ECG MONITORING SYSTEM | Cardiac Telecom Corp. | Jun 5, 1995 | SESE |
Top Applicants
- Cardiac Telecom Corp. — 1 clearance
- Remote Diagnostic Technologies , Ltd. — 1 clearance
