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

Substantially Equivalent

Ultraspect , Ltd.

FDA 510(k) clearance K050815 for XACT.CARDIAC & XPRESS.CARDIAC, Substantially Equivalent on 2005-04-26. Applicant: Ultraspect , Ltd..

Clearance details

Applicant: Ultraspect , Ltd.
Product code: Code KPS
Advisory panel: Radiology
Date received: 2005-03-31
Decision date: 2005-04-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Hafia, IL

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