nordicAudio (1.0)
K-Number: K251937 · 2026-03-20
ApplicantNordicneurolab AS
Decision Date2026-03-20
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
nordicAudio (1.0) is a medical device manufactured by Nordicneurolab AS. It received FDA 510(k) clearance on 2026-03-20 under approval number K251937. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the nordicAudio (1.0)?
nordicAudio (1.0) is a medical device that received FDA 510(k) clearance on 2026-03-20. It is manufactured by Nordicneurolab AS. The 510(k) number is K251937.
When was nordicAudio (1.0) approved by the FDA?
nordicAudio (1.0) received FDA 510(k) clearance on 2026-03-20, under approval number K251937.
What company makes nordicAudio (1.0)?
nordicAudio (1.0) is manufactured by Nordicneurolab AS.
What is the FDA product code for nordicAudio (1.0)?
The FDA product code for nordicAudio (1.0) is LNH.
Other Devices by Nordicneurolab AS
Related Devices (Code: LNH)
K162940MultiBand SENSEPhilips Medical Systems Nederland B.V.
K162183Vantage Galan 3T, MRT-3020, V4.0Toshibamedical Systems Corporation
K162102MAGNETOM Avantofit, MAGNETOM SkyrafitSiemens Medi Cal Solutions, Inc.
K162403HyperBandGe Medical Systems, LLC
K161795MAGNETOM ESSENZASiemens Medical Solutions USA, Inc.
K161973G-scan Brio, S-scanEsaote, S.p.A.
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.