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FDA 510(k) Application Details - K952826
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
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510(K) Number
K952826
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
SEIN ELECTRONICS CO., LTD.
ONE LETHBRIDGE PLAZA
MAHWAH, NJ 07430-2113 US
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Contact
BRENDA M KELLY
Other 510(k) Applications for this Contact
Regulation Number
870.1130
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Classification Product Code
DXN
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More FDA Info for this Product Code
Date Received
06/20/1995
Decision Date
11/14/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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