EZER, Portable X-ray System— 510(k) K190935

Name: FDA 510(k) clearance K190935
Creator: U.S. Food and Drug Administration
Published: 2019-12-19

Substantially Equivalent

Livermoretech, Inc.

FDA 510(k) clearance K190935 for EZER, Portable X-ray System, Substantially Equivalent on 2019-12-19. Applicant: Livermoretech, Inc.. Device class: 2.

Clearance details

Applicant: Livermoretech, Inc.
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2019-04-10
Decision date: 2019-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plano, TX, 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.