VIZION ULTRA— 510(k) K133139

Substantially Equivalent

Viztek, LLC

FDA 510(k) clearance K133139 for VIZION ULTRA, Substantially Equivalent on 2014-04-03. Applicant: Viztek, LLC. Device class: 2.

Clearance details

Applicant: Viztek, LLC
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2013-10-17
Decision date: 2014-04-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

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