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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 K862932
Device Name THE BIO-TEK UW-II
Applicant
Bio-Tek Instruments, Inc.
Hihgland Park
Box 998
Winooski,  VT  05404
Applicant Contact DAVE KLYSZEIKO
Correspondent
Bio-Tek Instruments, Inc.
Hihgland Park
Box 998
Winooski,  VT  05404
Correspondent Contact DAVE KLYSZEIKO
Regulation Number890.5290
Classification Product Code
IMJ  
Date Received08/04/1986
Decision Date 09/25/1986
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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