Cleared Traditional

QT GUARD PLUS ANALYSIS SYSTEM

K120770 · Ge Medical Systems Information Technologies · Cardiovascular
Dec 2012
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K120770 is an FDA 510(k) clearance for the QT GUARD PLUS ANALYSIS SYSTEM, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Ge Medical Systems Information Technologies (Wauwatosa, US). The FDA issued a Cleared decision on December 6, 2012, 267 days after receiving the submission on March 14, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K120770 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2012
Decision Date December 06, 2012
Days to Decision 267 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DPS — Electrocardiograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2340