VIZION DR— 510(k) K112661

Substantially Equivalent

Viztek, LLC

FDA 510(k) clearance K112661 for VIZION DR, Substantially Equivalent on 2011-10-20. Applicant: Viztek, LLC.

Clearance details

Applicant: Viztek, LLC
Product code: Code MQB
Advisory panel: Radiology
Date received: 2011-09-13
Decision date: 2011-10-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Naples, FL, US

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