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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 K844766
Device Name ND1100 BONE DENSITY SCANNER
Applicant
Nuclear Data, Inc.
Golf And Meacham Rd.S
Schaumburg,  IL  60196
Applicant Contact RAYMOND A DAVIDSON
Correspondent
Nuclear Data, Inc.
Golf And Meacham Rd.S
Schaumburg,  IL  60196
Correspondent Contact RAYMOND A DAVIDSON
Regulation Number892.1170
Classification Product Code
KGI  
Date Received12/07/1984
Decision Date 04/16/1985
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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