E-App— 510(k) K142719

Substantially Equivalent

Gc Medtech, LLC

FDA 510(k) clearance K142719 for E-App, Substantially Equivalent on 2015-05-20. Applicant: Gc Medtech, LLC. Device class: 2.

Clearance details

Applicant: Gc Medtech, LLC
Product code: Code JAQ
Device class: Class 2
Regulation: 21 CFR 892.5700
Advisory panel: Radiology
Date received: 2014-09-23
Decision date: 2015-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hialeah, 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.