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FDA 510(k) Application Details - K093872
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K093872
Device Name
Electrocardiograph
Applicant
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
NO. 9 SHUANGYUAN RD.
SHIJINGSHAN DISTRICT
BEIJING 100041 CN
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Contact
YAJING LI
Other 510(k) Applications for this Contact
Regulation Number
870.2340
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Classification Product Code
DPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/17/2009
Decision Date
03/31/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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