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FDA 510(k) Application Details - K134029
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
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510(K) Number
K134029
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE
702, 704 BLOCK C, TSINGHUA UNIS SCIENCE PARK
NO. 13 LANGSHAN RD HI-TECH IND
SHENZHEN, GUANGDONG 518057 CN
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Contact
PANG MING
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
12/31/2013
Decision Date
07/25/2014
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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