Cleared Traditional

Graffiti

K202189 · Ge Medical Systems Information Technologies, Inc. · Cardiovascular
Dec 2020
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K202189 is an FDA 510(k) clearance for the Graffiti, 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 8, 2020, 126 days after receiving the submission on August 4, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K202189 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 2020
Decision Date December 08, 2020
Days to Decision 126 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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