Cleared Traditional

EK12 V2 Algorithm

K221904 · Ge Medical Systems Information Technologies, Inc. · Cardiovascular
Dec 2022
Decision
173d
Days
Class 2
Risk

About This 510(k) Submission

K221904 is an FDA 510(k) clearance for the EK12 V2 Algorithm, 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 December 20, 2022, 173 days after receiving the submission on June 30, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K221904 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2022
Decision Date December 20, 2022
Days to Decision 173 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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