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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digitizer, Image, Radiological
510(k) Number K932760
Device Name DFS-2100
Applicant
Dba Systems, Inc.
1200 S. Woody Burke Rd.
Melbourne,  FL  32902
Applicant Contact KENNETH CAMPBELL
Correspondent
Dba Systems, Inc.
1200 S. Woody Burke Rd.
Melbourne,  FL  32902
Correspondent Contact KENNETH CAMPBELL
Regulation Number892.2030
Classification Product Code
LMA  
Date Received06/08/1993
Decision Date 10/20/1994
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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