FDA 510(k) Application Details - K093872

Device Classification Name Electrocardiograph

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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
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Regulation Number 870.2340

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Classification Product Code DPS
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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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