Cleared Traditional

K170155 - EK12 Algorithm
(FDA 510(k) Clearance)

K170155 · Ge Medical Systems Information Technologies, Inc. · Cardiovascular

Jun 2017

Decision

139d

Days

Class 2

Risk

K170155 is an FDA 510(k) clearance for the EK12 Algorithm. This device is classified as 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 June 6, 2017, 139 days after receiving the submission on January 18, 2017.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number	K170155 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 18, 2017
Decision Date	June 06, 2017
Days to Decision	139 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