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FDA 510(k) Application Details - K132998
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
510(K) Number
K132998
Device Name
Electrode, Cutaneous
Applicant
WANDY RUBBER INDUSTRIAL CO., LTD
NO. 48 LANE 392, FU TEH 1ST RD
NEW TAIPEI CITY 221 TW
Other 510(k) Applications for this Company
Contact
JACK YI
Other 510(k) Applications for this Contact
Regulation Number
882.1320
More FDA Info for this Regulation Number
Classification Product Code
GXY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/24/2013
Decision Date
12/20/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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