MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION— 510(k) K013620

Name: FDA 510(k) clearance K013620
Creator: U.S. Food and Drug Administration
Published: 2002-01-22

Substantially Equivalent

Medstone Intl., Inc.

FDA 510(k) clearance K013620 for MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION, Substantially Equivalent on 2002-01-22. Applicant: Medstone Intl., Inc.. Device class: 2.

Clearance details

Applicant: Medstone Intl., Inc.
Product code: Code IZF
Device class: Class 2
Regulation: 21 CFR 892.1740
Advisory panel: Radiology
Date received: 2001-11-05
Decision date: 2002-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aliso Viejo, CA, US

Download summary PDF View on FDA.gov ↗

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