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FDA 510(k) Application Details - K131899
Device Classification Name
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
890.5290
More FDA Info for this Regulation Number
Classification Product Code
IMJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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