ICTA— 510(k) K120260

Substantially Equivalent

Excel-Tech Ltd. (Xltek)

FDA 510(k) clearance K120260 for ICTA, Substantially Equivalent on 2012-06-29. Applicant: Excel-Tech Ltd. (Xltek). Device class: 2.

Clearance details

Applicant: Excel-Tech Ltd. (Xltek)
Product code: Code OMB
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2012-01-27
Decision date: 2012-06-29
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.