FDA 510(k)

3DIEMME RealGUIDE

K-Number: K173041 · 2018-12-20

Decision Date2018-12-20

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

3DIEMME RealGUIDE is the device name listed in this FDA 510(k) record. The listed applicant is 3Diemme , Ltd.. It received FDA 510(k) clearance on 2018-12-20 under 510(k) 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. The listed applicant is 3Diemme , Ltd.. The 510(k) number is K173041.

When did 3DIEMME RealGUIDE receive FDA 510(k) clearance?

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

Who is the listed applicant for 3DIEMME RealGUIDE?

The FDA 510(k) record lists 3Diemme , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3DIEMME RealGUIDE?

The FDA product code for 3DIEMME RealGUIDE is LLZ.

Related Devices (Code: LLZ)

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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.