DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM— 510(k) K102124

Name: FDA 510(k) clearance K102124
Creator: U.S. Food and Drug Administration
Published: 2010-10-22

Substantially Equivalent

VATECH Co., Ltd.

FDA 510(k) clearance K102124 for DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM, Substantially Equivalent on 2010-10-22. Applicant: VATECH Co., Ltd.. Device class: 2.

Clearance details

Applicant: VATECH Co., Ltd.
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2010-07-29
Decision date: 2010-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Secaucus, NJ, 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.