FDA 510(k) Application Details - K952827

Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive

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510(K) Number K952827
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
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Regulation Number 870.1130

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Classification Product Code DXN
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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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