Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
Device Facts
| Record ID | K253277 |
|---|---|
| Device Name | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P |
| Applicant | Ge Medical Systems Information Technologies, Inc. |
| Product Code | MHX · Cardiovascular |
| Decision Date | Jul 24, 2026 |
| 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.
