Cleared Traditional

Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P

K242562 · Ge Medical Systems Information Technologies, Inc. · Cardiovascular
Jul 2025
Decision
315d
Days
Class 2
Risk

About This 510(k) Submission

K242562 is an FDA 510(k) clearance for the Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Ge Medical Systems Information Technologies, Inc. (Wauwatosa, US). The FDA issued a Cleared decision on July 9, 2025, 315 days after receiving the submission on August 28, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K242562 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2024
Decision Date July 09, 2025
Days to Decision 315 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

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