PHT-6500, PHT-60CFO— 510(k) K130432

Substantially Equivalent

VATECH Co., Ltd.

FDA 510(k) clearance K130432 for PHT-6500, PHT-60CFO, Substantially Equivalent on 2013-05-31. Applicant: VATECH Co., Ltd.. Device class: 2.

Clearance details

Applicant: VATECH Co., Ltd.
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2013-02-21
Decision date: 2013-05-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Houston, 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.