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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 K964562
Device Name DTX-200 BONE DENSITOMETER
Applicant
Osteometer Meditech A/S
3003 Lbj Freeway
Suite 100
Dallas,  TX  75234
Applicant Contact BERT HUDSON
Correspondent
Osteometer Meditech A/S
3003 Lbj Freeway
Suite 100
Dallas,  TX  75234
Correspondent Contact BERT HUDSON
Regulation Number892.1170
Classification Product Code
KGI  
Date Received11/13/1996
Decision Date 08/22/1997
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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