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..

Clearance details

Applicant: Medien International Co, Ltd.
Product code: Code MQB
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 ↗

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