PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM— 510(k) K122155

Name: FDA 510(k) clearance K122155
Creator: U.S. Food and Drug Administration
Published: 2012-09-04

Substantially Equivalent

VATECH Co., Ltd.

FDA 510(k) clearance K122155 for PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, Substantially Equivalent on 2012-09-04. 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: 2012-07-20
Decision date: 2012-09-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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