Cleared Traditional

12SL ECG ANALYSIS PROGRAM

K141963 · Ge Medical Systems Information Technologies, Inc. · Cardiovascular
Feb 2015
Decision
202d
Days
Class 2
Risk

About This 510(k) Submission

K141963 is an FDA 510(k) clearance for the 12SL ECG ANALYSIS PROGRAM, 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 February 5, 2015, 202 days after receiving the submission on July 18, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K141963 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2014
Decision Date February 05, 2015
Days to Decision 202 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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