EMORY CARDIAC TOOLBOX VERSION 2.6— 510(k) K040141

Name: FDA 510(k) clearance K040141
Creator: U.S. Food and Drug Administration
Published: 2004-01-30

Substantially Equivalent

Syntermed, Inc.

FDA 510(k) clearance K040141 for EMORY CARDIAC TOOLBOX VERSION 2.6, Substantially Equivalent on 2004-01-30. Applicant: Syntermed, Inc.. Device class: 2.

Clearance details

Applicant: Syntermed, Inc.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2004-01-22
Decision date: 2004-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.