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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
510(k) Number K920939
Device Name DYNATRON 300 ULRASOUND
Applicant
Dynatronics Laser Corp.
470 Lawndale Dr., Bldg.
D
Salt Lake City,  UT  84115
Applicant Contact ROBERT J CARDON
Correspondent
Dynatronics Laser Corp.
470 Lawndale Dr., Bldg.
D
Salt Lake City,  UT  84115
Correspondent Contact ROBERT J CARDON
Regulation Number890.5860
Classification Product Code
IMG  
Date Received02/27/1992
Decision Date 03/04/1993
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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