DAMON D.E.T.E.C.T IMAGE ENHANCER

System, Image Processing, Radiological

DAMON CORP.

The following data is part of a premarket notification filed by Damon Corp. with the FDA for Damon D.e.t.e.c.t Image Enhancer.

Pre-market Notification Details

Device IDK874865
510k NumberK874865
Device Name:DAMON D.E.T.E.C.T IMAGE ENHANCER
ClassificationSystem, Image Processing, Radiological
Applicant DAMON CORP. 45 WEST ST. SUITE 2 Attleboro,  MA  02703
ContactJames R Veale
CorrespondentJames R Veale
DAMON CORP. 45 WEST ST. SUITE 2 Attleboro,  MA  02703
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-11-27
Decision Date1987-12-23

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