Nicolet EDX
K-Number: K243982 · 2025-01-22
ApplicantNatus Neurology Incorporated
Decision Date2025-01-22
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Nicolet EDX is a medical device manufactured by Natus Neurology Incorporated. It received FDA 510(k) clearance on 2025-01-22 under approval number K243982. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Nicolet EDX?
Nicolet EDX is a medical device that received FDA 510(k) clearance on 2025-01-22. It is manufactured by Natus Neurology Incorporated. The 510(k) number is K243982.
When was Nicolet EDX approved by the FDA?
Nicolet EDX received FDA 510(k) clearance on 2025-01-22, under approval number K243982.
What company makes Nicolet EDX?
Nicolet EDX is manufactured by Natus Neurology Incorporated.
What is the FDA product code for Nicolet EDX?
The FDA product code for Nicolet EDX is GWF.
Other Devices by Natus Neurology Incorporated
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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.