21 CFR 870.1025 — Detector And Alarm, Arrhythmia
Cardiovascular (CV) · Part 870 Subpart B—Cardiovascular Diagnostic Devices · § 870.1025
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | 2 | 398 | |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 | 422 | |
| MLD | Monitor, St Segment With Alarm | 2 | 14 | |
| MXD | Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) | 2 | 32 | Implant |
| QYW | Hospital Cardiac Telemetry | 2 | 2 | Life-Sustaining |
| QYX | Outpatient Cardiac Telemetry | 2 | 21 |
Special Controls
DSI — Detector And Alarm, Arrhythmia
*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.
eCFR
DSI — Detector And Alarm, Arrhythmia
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.
Ecfr Llm
MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
*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.
eCFR
MLD — Monitor, St Segment With Alarm
*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.
eCFR
MXD — Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
*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.
eCFR
QYW — Hospital Cardiac Telemetry
*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.
eCFR
QYX — Outpatient Cardiac Telemetry
*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.
eCFR
