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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
510(k) Number K851937
Device Name SONOMED 4
Applicant
Robert Bosch Corp.
Flower Field Bldg. #17
Mill Pond Rd.
St. James,  NY  11780
Applicant Contact ANDREW SCHEEFFER
Correspondent
Robert Bosch Corp.
Flower Field Bldg. #17
Mill Pond Rd.
St. James,  NY  11780
Correspondent Contact ANDREW SCHEEFFER
Regulation Number890.5300
Classification Product Code
IMI  
Date Received04/15/1985
Decision Date 07/17/1985
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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