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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 K131309
Device Name SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ
Applicant
Ibramed Equipamentos Medicos
18851 NE 29th Ave.
720
Aventura,  FL  33180
Applicant Contact TARA CONRAD
Correspondent
Ibramed Equipamentos Medicos
18851 NE 29th Ave.
720
Aventura,  FL  33180
Correspondent Contact TARA CONRAD
Regulation Number890.5300
Classification Product Code
IMI  
Date Received05/07/2013
Decision Date 01/27/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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