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FDA 510(k) Application Details - K190886
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K190886
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
Joytech Healthcare Co., Ltd
No. 365, Wuzhou Road, Yuhang Economic Development Zone
Hangzhou City
Hangzhou 311100 CN
Other 510(k) Applications for this Company
Contact
Ren Yunhua
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
04/04/2019
Decision Date
07/29/2019
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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