LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CM— 510(k) K132874

Name: FDA 510(k) clearance K132874
Creator: U.S. Food and Drug Administration
Published: 2014-02-21

Substantially Equivalent

Nucletron B.V.

FDA 510(k) clearance K132874 for LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CM, Substantially Equivalent on 2014-02-21. Applicant: Nucletron B.V.. Device class: 2.

Clearance details

Applicant: Nucletron B.V.
Product code: Code JAQ
Device class: Class 2
Regulation: 21 CFR 892.5700
Advisory panel: Radiology
Date received: 2013-09-13
Decision date: 2014-02-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Veenendaal, NL

Download summary PDF View on FDA.gov ↗

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