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FDA 510(k)

Nucleus.io

K-Number: K203249 · 2020-12-04

ApplicantNucleushealth, LLC
Decision Date2020-12-04
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Nucleus.io is a medical device manufactured by Nucleushealth, LLC. It received FDA 510(k) clearance on 2020-12-04 under approval number K203249. 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 Nucleus.io?

Nucleus.io is a medical device that received FDA 510(k) clearance on 2020-12-04. It is manufactured by Nucleushealth, LLC. The 510(k) number is K203249.

When was Nucleus.io approved by the FDA?

Nucleus.io received FDA 510(k) clearance on 2020-12-04, under approval number K203249.

What company makes Nucleus.io?

Nucleus.io is manufactured by Nucleushealth, LLC.

What is the FDA product code for Nucleus.io?

The FDA product code for Nucleus.io is LLZ.

Other Devices by Nucleushealth, LLC

K171130Nucleus Image Management System

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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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