K Number
K242562Device Name
Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
Date Cleared
2025-07-09
(315 days)
Regulation Number
870.1025AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
More Information
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
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.(b)
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.
N/A