CEQUAL-QUANTITATIVE ANALYSIS

System, Tomography, Computed, Emission

NUCCARDIAC SOFTWARE, INC.

The following data is part of a premarket notification filed by Nuccardiac Software, Inc. with the FDA for Cequal-quantitative Analysis.

Pre-market Notification Details

Device IDK942363
510k NumberK942363
Device Name:CEQUAL-QUANTITATIVE ANALYSIS
ClassificationSystem, Tomography, Computed, Emission
Applicant NUCCARDIAC SOFTWARE, INC. 20503 YORBA LINDA BLVD. SUITE 442 Torba Linda,  CA  92686
ContactKenneth F Van Train
CorrespondentKenneth F Van Train
NUCCARDIAC SOFTWARE, INC. 20503 YORBA LINDA BLVD. SUITE 442 Torba Linda,  CA  92686
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-05-17
Decision Date1994-09-16

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