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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Densitometer, Bone
510(k) Number K941362
Device Name BONE MINERAL DENSITOMETER
Applicant
Hologic, Inc.
590 Lincoln St.
Waltham,  MA  02154
Applicant Contact ERIC V STETTEN,PH.D
Correspondent
Hologic, Inc.
590 Lincoln St.
Waltham,  MA  02154
Correspondent Contact ERIC V STETTEN,PH.D
Regulation Number892.1170
Classification Product Code
KGI  
Date Received03/21/1994
Decision Date 08/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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