GALAXY PLUS— 510(k) K132921

Substantially Equivalent

Medien International Co, Ltd.

FDA 510(k) clearance K132921 for GALAXY PLUS, Substantially Equivalent on 2014-01-17. Applicant: Medien International Co, Ltd.. Device class: 2.

Clearance details

Applicant: Medien International Co, Ltd.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2013-09-17
Decision date: 2014-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
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.