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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 K980125
Device Name REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOMETER
Applicant
Norland Corp.
West 6340 Hackbarth Rd.
Fort Atkinson,  WI  53538
Applicant Contact TERRY SCHWALANBERG
Correspondent
Norland Corp.
West 6340 Hackbarth Rd.
Fort Atkinson,  WI  53538
Correspondent Contact TERRY SCHWALANBERG
Regulation Number892.1170
Classification Product Code
KGI  
Date Received01/14/1998
Decision Date 05/20/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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