NHANES WHOLE BODY DXA REFERENCE DATABASE

Densitometer, Bone

HOLOGIC, INC.

The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Nhanes Whole Body Dxa Reference Database.

Pre-market Notification Details

Device IDK103265
510k NumberK103265
Device Name:NHANES WHOLE BODY DXA REFERENCE DATABASE
ClassificationDensitometer, Bone
Applicant HOLOGIC, INC. 35 CROSBY DR. Bedford,  MA  01730
ContactChristina Hurton
CorrespondentChristina Hurton
HOLOGIC, INC. 35 CROSBY DR. Bedford,  MA  01730
Product CodeKGI  
CFR Regulation Number892.1170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-11-04
Decision Date2011-03-16
Summary:summary

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