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FDA 510(k) Application Details - K003282
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K003282
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
SEIN ELECTRONICS CO., LTD.
196 ANYANG 7 DONG, MANAN-KU
YOUCHEON FACTOPIA RM. #506
ANYANG-CITY, KYUNGKI-DO 206 KR
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Contact
WON KY KIM
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
10/19/2000
Decision Date
11/01/2000
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
Y
Expedited Review
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