Cleared Special

MARS HOLTER ANALYSIS WORKSTATION

K132437 · Ge Medical Systems Information Technologies, Inc. · Cardiovascular
Dec 2013
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K132437 is an FDA 510(k) clearance for the MARS HOLTER ANALYSIS WORKSTATION, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Ge Medical Systems Information Technologies, Inc. (Wauwatosa, US). The FDA issued a Cleared decision on December 4, 2013, 121 days after receiving the submission on August 5, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K132437 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2013
Decision Date December 04, 2013
Days to Decision 121 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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