Cleared Traditional

Monitor B125, Monitor B105

K201941 · Ge Medical Systems Information Technologies, Inc. · Cardiovascular
Nov 2020
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K201941 is an FDA 510(k) clearance for the Monitor B125, Monitor B105, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Ge Medical Systems Information Technologies, Inc. (Milwaukee, US). The FDA issued a Cleared decision on November 4, 2020, 114 days after receiving the submission on July 13, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K201941 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 2020
Decision Date November 04, 2020
Days to Decision 114 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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