Natus NeuroWorks
K-Number: K180421 · 2018-03-14
Decision Date2018-03-14
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Natus NeuroWorks is a medical device manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). It received FDA 510(k) clearance on 2018-03-14 under approval number K180421. The device is classified under product code OMB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Natus NeuroWorks?
Natus NeuroWorks is a medical device that received FDA 510(k) clearance on 2018-03-14. It is manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). The 510(k) number is K180421.
When was Natus NeuroWorks approved by the FDA?
Natus NeuroWorks received FDA 510(k) clearance on 2018-03-14, under approval number K180421.
What company makes Natus NeuroWorks?
Natus NeuroWorks is manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek).
What is the FDA product code for Natus NeuroWorks?
The FDA product code for Natus NeuroWorks is OMB.
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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.