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FDA 510(k) Application Details - K080276
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
510(K) Number
K080276
Device Name
Electrode, Cutaneous
Applicant
CATHAY HEALTHCARE EQUIPMENT MANUFACTURING, INC
FLEMINGTON CT
SUITE 155
LA MIRADA, CA 90638 US
Other 510(k) Applications for this Company
Contact
BRANDON CHOI
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
02/04/2008
Decision Date
08/04/2008
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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