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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 K901950
Device Name DITER ULTRASONIC S 3000
Applicant
Diter Elektroniikka OY
Sun Strategic Universal Networ
230 Park Ave.
New York,  NY  10169
Applicant Contact KADER AFIF
Correspondent
Diter Elektroniikka OY
Sun Strategic Universal Networ
230 Park Ave.
New York,  NY  10169
Correspondent Contact KADER AFIF
Regulation Number890.5300
Classification Product Code
IMI  
Date Received05/01/1990
Decision Date 07/27/1990
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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