Natus NeuroWorks— 510(k) K180421

Name: FDA 510(k) clearance K180421
Creator: U.S. Food and Drug Administration
Published: 2018-03-14

Substantially Equivalent

Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

FDA 510(k) clearance K180421 for Natus NeuroWorks, Substantially Equivalent on 2018-03-14. Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). Device class: 2.

Clearance details

Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Product code: Code OMB
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2018-02-16
Decision date: 2018-03-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Oakville, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.