EZER, Portable X-ray System

System, X-ray, Mobile

Livermoretech Inc.

The following data is part of a premarket notification filed by Livermoretech Inc. with the FDA for Ezer, Portable X-ray System.

Pre-market Notification Details

Device IDK193535
510k NumberK193535
Device Name:EZER, Portable X-ray System
ClassificationSystem, X-ray, Mobile
Applicant Livermoretech Inc. 801 North Jupiter Rd, Suite 200 Plano,  TX  75074
ContactJae Hong Kim
CorrespondentDave Kim
Mtech Group 7707 Fannin St. Ste 200 Houston,  TX  77054
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-20
Decision Date2020-05-07

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