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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 K842801
Device Name ULTRAMED 11S601
Applicant
Robert Bosch Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Robert Bosch Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5290
Classification Product Code
IMJ  
Date Received07/17/1984
Decision Date 08/01/1984
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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