Cleared Traditional

Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P

K213490 · Ge Medical Systems Information Technologies, Inc. · Cardiovascular
Apr 2022
Decision
151d
Days
Class 2
Risk

About This 510(k) Submission

K213490 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 April 1, 2022, 151 days after receiving the submission on November 1, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K213490 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 2021
Decision Date April 01, 2022
Days to Decision 151 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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