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FDA 510(k) Application Details - K112431
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K112431
Device Name
Electrocardiograph
Applicant
SHENZHEN BIOCARE ELECTRONICS CO., LTD
P.O. BOX 237-023
SHANGHAI 200237 CN
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Contact
Diana Hong
Other 510(k) Applications for this Contact
Regulation Number
870.2340
More FDA Info for this Regulation Number
Classification Product Code
DPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/23/2011
Decision Date
09/22/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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