FDA 510(k) Application Details - K131926

Device Classification Name Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

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510(K) Number K131926
Device Name Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Applicant IBRAMED EQUIPAMENTOS MEDICOS
18851 NE 29TH AVE 720
AVENTURA, FL 33180 US
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Contact TARA CONRAD
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Regulation Number 890.5290

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Classification Product Code IMJ
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Date Received 06/26/2013
Decision Date 07/24/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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