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FDA 510(k) Application Details - K031174
Device Classification Name
Electrode, Electrocardiograph
More FDA Info for this Device
510(K) Number
K031174
Device Name
Electrode, Electrocardiograph
Applicant
WANDY RUBBER INDUSTRIAL CO., LTD
NO.24, ALLEY 37, LANE 392
FU TEH 1ST RD.
SHI-CHIH 221 TW
Other 510(k) Applications for this Company
Contact
JANIS YANG
Other 510(k) Applications for this Contact
Regulation Number
870.2360
More FDA Info for this Regulation Number
Classification Product Code
DRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/14/2003
Decision Date
07/10/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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