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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, High-Voltage, X-Ray, Diagnostic
510(k) Number K902986
Device Name G.E. DXD 325/350/350II/DXD 525/525II GENERATORS
Applicant
Electromek Diagnostic Systems, Inc.
412 Rte. 40 W.
Troy,  IL  62294
Applicant Contact JAMES HENRICHS
Correspondent
Electromek Diagnostic Systems, Inc.
412 Rte. 40 W.
Troy,  IL  62294
Correspondent Contact JAMES HENRICHS
Regulation Number892.1700
Classification Product Code
IZO  
Date Received06/26/1990
Decision Date 02/13/1991
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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