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FDA 510(k) Application Details - K170954
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K170954
Device Name
Electrocardiograph
Applicant
CONTEC Medical Systems Co.,Ltd
No.112 Qinhuang West Street, Economic& Technical Development
Qinhuangdao 066004 CN
Other 510(k) Applications for this Company
Contact
Xueyong Li
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
03/31/2017
Decision Date
05/30/2017
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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