K180290

Substantially Equivalent

Natus Brain Monitor Amplifier

Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Product code: GWQ
Advisory panel: Neurology
Date received: 2018-02-01
Decision date: 2018-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakville, CA

Download summary PDF View on FDA.gov ↗

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