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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 K861233
Device Name DUAL PHOTON BONE DENSITOMETER
Applicant
Medical and Scientific Enterprises, Inc.
P.O. Box 661
Concord,  MA  01742
Applicant Contact EDUARD J BOTZ
Correspondent
Medical and Scientific Enterprises, Inc.
P.O. Box 661
Concord,  MA  01742
Correspondent Contact EDUARD J BOTZ
Regulation Number892.1170
Classification Product Code
KGI  
Date Received04/01/1986
Decision Date 03/03/1987
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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