Quantib Brain 1.2
K-Number: K163013 · 2017-01-06
ApplicantQuantib B.V.
Decision Date2017-01-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Quantib Brain 1.2 is a medical device manufactured by Quantib B.V.. It received FDA 510(k) clearance on 2017-01-06 under approval number K163013. 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 Brain 1.2?
Quantib Brain 1.2 is a medical device that received FDA 510(k) clearance on 2017-01-06. It is manufactured by Quantib B.V.. The 510(k) number is K163013.
When was Quantib Brain 1.2 approved by the FDA?
Quantib Brain 1.2 received FDA 510(k) clearance on 2017-01-06, under approval number K163013.
What company makes Quantib Brain 1.2?
Quantib Brain 1.2 is manufactured by Quantib B.V..
What is the FDA product code for Quantib Brain 1.2?
The FDA product code for Quantib Brain 1.2 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.