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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K881431
Device Name SIEMENS STEREODYNATOR 828
Applicant
Elmed, Inc.
60 W. Fay Ave.
Addison,  IL  60101
Applicant Contact KARL HAUSNER
Correspondent
Elmed, Inc.
60 W. Fay Ave.
Addison,  IL  60101
Correspondent Contact KARL HAUSNER
Regulation Number890.5850
Classification Product Code
IPF  
Date Received04/05/1988
Decision Date 04/16/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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