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FDA 510(k)

3DIEMME RealGUIDE

K-Number: K173041 · 2018-12-20

Applicant3Diemme , Ltd.
Decision Date2018-12-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3DIEMME RealGUIDE is a medical device manufactured by 3Diemme , Ltd.. It received FDA 510(k) clearance on 2018-12-20 under approval number K173041. 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 3DIEMME RealGUIDE?

3DIEMME RealGUIDE is a medical device that received FDA 510(k) clearance on 2018-12-20. It is manufactured by 3Diemme , Ltd.. The 510(k) number is K173041.

When was 3DIEMME RealGUIDE approved by the FDA?

3DIEMME RealGUIDE received FDA 510(k) clearance on 2018-12-20, under approval number K173041.

What company makes 3DIEMME RealGUIDE?

3DIEMME RealGUIDE is manufactured by 3Diemme , Ltd..

What is the FDA product code for 3DIEMME RealGUIDE?

The FDA product code for 3DIEMME RealGUIDE is LLZ.

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Official Source

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