FDA 510(k) Application Details - K131899

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

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510(K) Number K131899
Device Name Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Applicant SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
No. 3 Building XiliBaimang Xusheng Industrial Estate
Nanshan
SHENZHEN 518108 CN
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Contact JIANPING KANG
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Regulation Number 890.5290

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Classification Product Code IMJ
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Date Received 06/25/2013
Decision Date 03/14/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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