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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 K884625
Device Name DPX BONE DENSITOMETER FOR TOTAL BODY BONE DENSITY
Applicant
Lunar
313 W. Beltline Hwy.
Madison,  WI  53713
Applicant Contact B MAZESS,PHD
Correspondent
Lunar
313 W. Beltline Hwy.
Madison,  WI  53713
Correspondent Contact B MAZESS,PHD
Regulation Number892.1170
Classification Product Code
KGI  
Date Received11/04/1988
Decision Date 06/23/1989
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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