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FDA 510(k) Application Details - K090936
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K090936
Device Name
Electrocardiograph
Applicant
CONTEC MEDICAL SYSTEM CO., LTD.
SUITE 8D , ZHONGXIN ZHONGSHAN
MANSION, NO. 19, LANE 999,
ZHONG SHAN, SHANGHAI 20030 CN
Other 510(k) Applications for this Company
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
04/02/2009
Decision Date
08/25/2009
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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