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FDA 510(k) Application Details - K093327
Device Classification Name
Electrode, Electrocardiograph
More FDA Info for this Device
510(K) Number
K093327
Device Name
Electrode, Electrocardiograph
Applicant
SHANGHAI INTCO ELECTRODE MANUFACTURING CO., LTD.
814 AIRPORT WAY
SANDPOINT, ID 83864 US
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Contact
CHRIS HEALY
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
10/26/2009
Decision Date
05/10/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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