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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 K915535
Device Name FOREARM SOFTWARE FOR LUNAR DPX SERIES BONE DESITOM
Applicant
Lunar
313 W. Beltline Hwy.
Madison,  WI  53713
Applicant Contact RICHARD B MAZESS
Correspondent
Lunar
313 W. Beltline Hwy.
Madison,  WI  53713
Correspondent Contact RICHARD B MAZESS
Regulation Number892.1170
Classification Product Code
KGI  
Date Received12/09/1991
Decision Date 02/27/1992
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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