ORG-9200A
Device Facts
| Record ID | K002068 |
|---|---|
| Device Name | ORG-9200A |
| Applicant | Nihon Kohden America, Inc. |
| Product Code | DSI · Cardiovascular |
| Decision Date | Feb 8, 2001 |
| 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.
