Quantib AI Node
K-Number: K200899 · 2020-06-15
ApplicantQuantib B.V.
Decision Date2020-06-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Quantib AI Node is a medical device manufactured by Quantib B.V.. It received FDA 510(k) clearance on 2020-06-15 under approval 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. It is manufactured by Quantib B.V.. The 510(k) number is K200899.
When was Quantib AI Node approved by the FDA?
Quantib AI Node received FDA 510(k) clearance on 2020-06-15, under approval number K200899.
What company makes Quantib AI Node?
Quantib AI Node is manufactured by Quantib B.V..
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.