BIOMONITOR IV (471155)
Device Facts
| Record ID | K261074 |
|---|---|
| Device Name | BIOMONITOR IV (471155) |
| Applicant | Biotronik, Inc. |
| Product Code | MXD · Cardiovascular |
| Decision Date | May 1, 2026 |
| Decision | SESE |
| Submission Type | Special |
| 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.
