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FDA 510(k)

Emprint Visualization Application

K-Number: K192038 · 2019-12-02

ApplicantCovidien, LLC
Decision Date2019-12-02
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Emprint Visualization Application is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2019-12-02 under approval number K192038. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Emprint Visualization Application?

Emprint Visualization Application is a medical device that received FDA 510(k) clearance on 2019-12-02. It is manufactured by Covidien, LLC. The 510(k) number is K192038.

When was Emprint Visualization Application approved by the FDA?

Emprint Visualization Application received FDA 510(k) clearance on 2019-12-02, under approval number K192038.

What company makes Emprint Visualization Application?

Emprint Visualization Application is manufactured by Covidien, LLC.

What is the FDA product code for Emprint Visualization Application?

The FDA product code for Emprint Visualization Application is LLZ.

Related Clinical Trials

NCT03031587 Validation of Thermometric Cardiac Imaging by MRI COMPLETED

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Official Source

View on FDA Database →

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

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