HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS

Densitometer, Bone

HOLOGIC, INC.

The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Hologic Qdr Series X-ray Boe Densitometers.

Pre-market Notification Details

Device IDK963363
510k NumberK963363
Device Name:HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS
ClassificationDensitometer, Bone
Applicant HOLOGIC, INC. 590 LINCOLN ST. Waltham,  MA  02154
ContactEric Von Stetten, Ph.d.
CorrespondentEric Von Stetten, Ph.d.
HOLOGIC, INC. 590 LINCOLN ST. Waltham,  MA  02154
Product CodeKGI  
CFR Regulation Number892.1170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-08-27
Decision Date1996-11-22
Summary:summary

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