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FDA 510(k) Application Details - K190133
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
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510(K) Number
K190133
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
Health & Life Co., Ltd.
9F. No.186, Jian Yi Road
Zhonghe District, New Taipei City 23553 TW
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Contact
JS Hsu
Other 510(k) Applications for this Contact
Regulation Number
870.1130
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Classification Product Code
DXN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/28/2019
Decision Date
06/13/2019
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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