Cleared Traditional

MARS HOLTER ANALYSIS WORKSTATION

K093141 · Ge Medical Systems Information Technologies · Cardiovascular
Dec 2009
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K093141 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 (Wauwatosa, US). The FDA issued a Cleared decision on December 29, 2009, 85 days after receiving the submission on October 5, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K093141 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 2009
Decision Date December 29, 2009
Days to Decision 85 days
Submission Type Traditional
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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