DELL U3014 WITH QUBYX PERFECTLUM BUNDLE— 510(k) K131601

Name: FDA 510(k) clearance K131601
Creator: U.S. Food and Drug Administration
Published: 2014-07-07

Substantially Equivalent

Qubyx Limited

FDA 510(k) clearance K131601 for DELL U3014 WITH QUBYX PERFECTLUM BUNDLE, Substantially Equivalent on 2014-07-07. Applicant: Qubyx Limited. Device class: 2.

Clearance details

Applicant: Qubyx Limited
Product code: Code PGY
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2013-06-03
Decision date: 2014-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nice, FR

Download summary PDF View on FDA.gov ↗

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