WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE— 510(k) K080784

Name: FDA 510(k) clearance K080784
Creator: U.S. Food and Drug Administration
Published: 2008-04-02

Substantially Equivalent

Ultraspect , Ltd.

FDA 510(k) clearance K080784 for WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE, Substantially Equivalent on 2008-04-02. Applicant: Ultraspect , Ltd.. Device class: 2.

Clearance details

Applicant: Ultraspect , Ltd.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2008-03-20
Decision date: 2008-04-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Haifa, IL

Download summary PDF View on FDA.gov ↗

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