EMORY CARDIAC TOOLBOX* 2.0 EXECUTING ON NUCLEAR MEDICINE COMPUTERS— 510(k) K992450

Name: FDA 510(k) clearance K992450
Creator: U.S. Food and Drug Administration
Published: 1999-10-07

Substantially Equivalent

Emory University

FDA 510(k) clearance K992450 for EMORY CARDIAC TOOLBOX* 2.0 EXECUTING ON NUCLEAR MEDICINE COMPUTERS, Substantially Equivalent on 1999-10-07. Applicant: Emory University. Device class: 2.

Clearance details

Applicant: Emory University
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 1999-07-22
Decision date: 1999-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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