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FDA 510(k) Application Details - K190207
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K190207
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
Shenzhen Viatom Technology Co., Ltd.
Block 67, Xin'an Street, Boan District
Shen Zhen 518101 CN
Other 510(k) Applications for this Company
Contact
Zhou Saixin
Other 510(k) Applications for this Contact
Regulation Number
870.1130
More FDA Info for this Regulation Number
Classification Product Code
DXN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/04/2019
Decision Date
08/19/2019
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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