HOLOGIC MODELS BLK-1, DPA/QDR-1 & QCT-1

Densitometer, Bone

HOLOGIC, INC.

The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Hologic Models Blk-1, Dpa/qdr-1 & Qct-1.

Pre-market Notification Details

Device IDK871446
510k NumberK871446
Device Name:HOLOGIC MODELS BLK-1, DPA/QDR-1 & QCT-1
ClassificationDensitometer, Bone
Applicant HOLOGIC, INC. 590 LINCOLN ST. Waltham,  MA  02154
ContactAlan Hochberg
CorrespondentAlan Hochberg
HOLOGIC, INC. 590 LINCOLN ST. Waltham,  MA  02154
Product CodeKGI  
CFR Regulation Number892.1170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-04-13
Decision Date1987-10-20

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