DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX)— 510(k) K092103

Name: FDA 510(k) clearance K092103
Creator: U.S. Food and Drug Administration
Published: 2009-10-09

Substantially Equivalent

VATECH Co., Ltd.

FDA 510(k) clearance K092103 for DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX), Substantially Equivalent on 2009-10-09. Applicant: VATECH Co., Ltd.. Device class: 2.

Clearance details

Applicant: VATECH Co., Ltd.
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2009-07-14
Decision date: 2009-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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