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FDA 510(k) Application Details - K173028
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K173028
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
HealthSTATS International Pte Ltd
3 Ang Mo Kio Street 62
#08-25/26, Link@Amk
Singapore 536199 SG
Other 510(k) Applications for this Company
Contact
Ngak Hwee Chua
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
09/28/2017
Decision Date
06/21/2018
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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