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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K992450
Device Name EMORY CARDIAC TOOLBOX* 2.0 EXECUTING ON NUCLEAR MEDICINE COMPUTERS
Applicant
Emory University
1364 Clifton Rd. NE
Rm. E163
Atlanta,  GA  30322
Applicant Contact ERNEST V GARCIA
Correspondent
Emory University
1364 Clifton Rd. NE
Rm. E163
Atlanta,  GA  30322
Correspondent Contact ERNEST V GARCIA
Regulation Number892.1200
Classification Product Code
KPS  
Date Received07/22/1999
Decision Date 10/07/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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