XACT.CARDIAC & XPRESS.CARDIAC— 510(k) K050815

Name: FDA 510(k) clearance K050815
Creator: U.S. Food and Drug Administration
Published: 2005-04-26

Substantially Equivalent

Ultraspect , Ltd.

FDA 510(k) clearance K050815 for XACT.CARDIAC & XPRESS.CARDIAC, Substantially Equivalent on 2005-04-26. 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: 2005-03-31
Decision date: 2005-04-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Hafia, IL

Download summary PDF View on FDA.gov ↗

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