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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
510(k) Number K934151
Device Name MAGNATHERM MODEL 1000 SS
Applicant
Intl. Medical Electronics , Ltd.
3939 Broadway
Kansas City,  MO  64111
Applicant Contact EUGENE C LIPSKY
Correspondent
Intl. Medical Electronics , Ltd.
3939 Broadway
Kansas City,  MO  64111
Correspondent Contact EUGENE C LIPSKY
Regulation Number890.5290
Classification Product Code
IMJ  
Date Received08/25/1993
Decision Date 02/17/1995
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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