Trex_HD— 510(k) K162595

Name: FDA 510(k) clearance K162595
Creator: U.S. Food and Drug Administration
Published: 2016-11-04

Substantially Equivalent

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

FDA 510(k) clearance K162595 for Trex_HD, Substantially Equivalent on 2016-11-04. 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 GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2016-09-15
Decision date: 2016-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
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.