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FDA 510(k) Application Details - K160092
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K160092
Device Name
Electrocardiograph
Applicant
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD.
#A735,Shenzhen Mingyou Industrial Product
Exhibition & Procurement Center,
Shenzhen 518102 CN
Other 510(k) Applications for this Company
Contact
Hongbo Zhong
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
01/15/2016
Decision Date
02/12/2016
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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