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FDA 510(k)

Graffiti

K-Number: K202189 · 2020-12-08

Decision Date2020-12-08
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Graffiti is a medical device manufactured by Ge Medical Systems Information Technologies, Inc.. It received FDA 510(k) clearance on 2020-12-08 under approval number K202189. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Graffiti?

Graffiti is a medical device that received FDA 510(k) clearance on 2020-12-08. It is manufactured by Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K202189.

When was Graffiti approved by the FDA?

Graffiti received FDA 510(k) clearance on 2020-12-08, under approval number K202189.

What company makes Graffiti?

Graffiti is manufactured by Ge Medical Systems Information Technologies, Inc..

What is the FDA product code for Graffiti?

The FDA product code for Graffiti is DQK.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.