QDR-1000 AND WITH X-RAY BONE DENSITOMETER

Densitometer, Bone

HOLOGIC, INC.

The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Qdr-1000 And With X-ray Bone Densitometer.

Pre-market Notification Details

Device IDK905691
510k NumberK905691
Device Name:QDR-1000 AND WITH X-RAY BONE DENSITOMETER
ClassificationDensitometer, Bone
Applicant HOLOGIC, INC. 590 LINCOLN ST. Waltham,  MA  02154
ContactVon Stetten
CorrespondentVon Stetten
HOLOGIC, INC. 590 LINCOLN ST. Waltham,  MA  02154
Product CodeKGI  
CFR Regulation Number892.1170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-19
Decision Date1991-05-15

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