Quantib Brain 1
K-Number: K153351 · 2016-06-17
ApplicantQuantib B.V.
Decision Date2016-06-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Quantib Brain 1 is a medical device manufactured by Quantib B.V.. It received FDA 510(k) clearance on 2016-06-17 under approval number K153351. 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?
Quantib Brain 1 is a medical device that received FDA 510(k) clearance on 2016-06-17. It is manufactured by Quantib B.V.. The 510(k) number is K153351.
When was Quantib Brain 1 approved by the FDA?
Quantib Brain 1 received FDA 510(k) clearance on 2016-06-17, under approval number K153351.
What company makes Quantib Brain 1?
Quantib Brain 1 is manufactured by Quantib B.V..
What is the FDA product code for Quantib Brain 1?
The FDA product code for Quantib Brain 1 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.