BONE MINERAL DENSITOMETER

Densitometer, Bone

HOLOGIC, INC.

The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Bone Mineral Densitometer.

Pre-market Notification Details

Device IDK941362
510k NumberK941362
Device Name:BONE MINERAL DENSITOMETER
ClassificationDensitometer, Bone
Applicant HOLOGIC, INC. 590 LINCOLN ST. Waltham,  MA  02154
ContactEric V Stetten,ph.d
CorrespondentEric V 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 Received1994-03-21
Decision Date1995-08-30

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