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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 K040616
Device Name CARDIOMD-AC
Applicant
DANISH DIAGNOSTIC DEVELOPMENT A/S
DR. NEERGAARDSVEJ 5F
HORSHOLM,  DK
Applicant Contact NIELS SORENSEN
Correspondent
UNDERWRITERS LABORATORIES, INC.
12 LABORATORY DR.
RESEARCH TRIANGLE,  NC  27709
Correspondent Contact SUSAN GILL
Regulation Number892.1200
Classification Product Code
KPS  
Date Received03/09/2004
Decision Date 03/24/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
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