NeuralScan System
K-Number: K192753 · 2020-03-17
ApplicantMedeia, Inc.
Decision Date2020-03-17
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
NeuralScan System is a medical device manufactured by Medeia, Inc.. It received FDA 510(k) clearance on 2020-03-17 under approval number K192753. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NeuralScan System?
NeuralScan System is a medical device that received FDA 510(k) clearance on 2020-03-17. It is manufactured by Medeia, Inc.. The 510(k) number is K192753.
When was NeuralScan System approved by the FDA?
NeuralScan System received FDA 510(k) clearance on 2020-03-17, under approval number K192753.
What company makes NeuralScan System?
NeuralScan System is manufactured by Medeia, Inc..
What is the FDA product code for NeuralScan System?
The FDA product code for NeuralScan System is GWQ.
Other Devices by Medeia, Inc.
Related Devices (Code: GWQ)
K163163XLTEK EMU40EX EEG HeadboxNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
K162595Trex_HDNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
K150498Discovery 24Brainmaster Technologies, Inc.
K170138NEURONAUTEBioserenity
K171781eVox SystemEvoke Neuroscience, Inc.
K171124Nihon Kohden Wireless Input Unit WEE-1200Nihon Kohden Corporation
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.