XLTEK LED GOGGLES, MODEL LED-01— 510(k) K011794

Name: FDA 510(k) clearance K011794
Creator: U.S. Food and Drug Administration
Published: 2001-10-01

Substantially Equivalent

Excel Tech. , Ltd.

FDA 510(k) clearance K011794 for XLTEK LED GOGGLES, MODEL LED-01, Substantially Equivalent on 2001-10-01. Applicant: Excel Tech. , Ltd.. Device class: 2.

Clearance details

Applicant: Excel Tech. , Ltd.
Product code: Code GWE
Device class: Class 2
Regulation: 21 CFR 882.1890
Advisory panel: Neurology
Date received: 2001-06-08
Decision date: 2001-10-01
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.