FDA 510(k)

Quantib AI Node

K-Number: K200899 · 2020-06-15

Decision Date2020-06-15

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Quantib AI Node is the device name listed in this FDA 510(k) record. The listed applicant is Quantib B.V.. It received FDA 510(k) clearance on 2020-06-15 under 510(k) number K200899. 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 Quantib AI Node?

Quantib AI Node is a medical device that received FDA 510(k) clearance on 2020-06-15. The listed applicant is Quantib B.V.. The 510(k) number is K200899.

When did Quantib AI Node receive FDA 510(k) clearance?

Quantib AI Node received FDA 510(k) clearance on 2020-06-15, under 510(k) number K200899.

Who is the listed applicant for Quantib AI Node?

The FDA 510(k) record lists Quantib B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quantib AI Node?

The FDA product code for Quantib AI Node is 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.