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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 K931996
Device Name MODEL PDEXA BONE DENSITOMETER
Applicant
Norland Corp.
W6340 Hackbarth Rd.
Fort Atkinson,  WI  53538
Applicant Contact TERRY SCHWALENBERG
Correspondent
Norland Corp.
31 Gordan Rd.
Piscataway,  NJ  08854
Correspondent Contact John Monahan
Regulation Number892.1170
Classification Product Code
KGI  
Date Received04/23/1993
Decision Date 02/01/1995
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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