nordicBrainEx
K-Number: K163324 · 2017-01-27
ApplicantNordicneurolab AS
Decision Date2017-01-27
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
nordicBrainEx is a medical device manufactured by Nordicneurolab AS. It received FDA 510(k) clearance on 2017-01-27 under approval number K163324. 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 nordicBrainEx?
nordicBrainEx is a medical device that received FDA 510(k) clearance on 2017-01-27. It is manufactured by Nordicneurolab AS. The 510(k) number is K163324.
When was nordicBrainEx approved by the FDA?
nordicBrainEx received FDA 510(k) clearance on 2017-01-27, under approval number K163324.
What company makes nordicBrainEx?
nordicBrainEx is manufactured by Nordicneurolab AS.
What is the FDA product code for nordicBrainEx?
The FDA product code for nordicBrainEx is LLZ.
Other Devices by Nordicneurolab AS
Related Devices (Code: LLZ)
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.