CARDIOMD-AC

System, Tomography, Computed, Emission

DANISH DIAGNOSTIC DEVELOPMENT A/S

The following data is part of a premarket notification filed by Danish Diagnostic Development A/s with the FDA for Cardiomd-ac.

Pre-market Notification Details

Device IDK040616
510k NumberK040616
Device Name:CARDIOMD-AC
ClassificationSystem, Tomography, Computed, Emission
Applicant DANISH DIAGNOSTIC DEVELOPMENT A/S DR. NEERGAARDSVEJ 5F Horsholm,  DK
ContactNiels Sorensen
CorrespondentSusan Gill
UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle,  NC  27709
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedYes
Combination ProductNo
Date Received2004-03-09
Decision Date2004-03-24

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