PAX-500— 510(k) K082350

Substantially Equivalent

VATECH Co., Ltd.

FDA 510(k) clearance K082350 for PAX-500, Substantially Equivalent on 2008-10-10. Applicant: VATECH Co., Ltd..

Clearance details

Applicant: VATECH Co., Ltd.
Product code: Code OAS
Advisory panel: Radiology
Date received: 2008-08-15
Decision date: 2008-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

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