FDA 510(k) Application Details - K093102

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

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510(K) Number K093102
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant NIHON SEIMITSU SOKKI CO., LTD.
3F, 2-17-6 AKEBONO-CHO
TACHIKAWA- SHI, TOKYO 190-0012 JP
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Contact KOJI KUBO
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 10/01/2009
Decision Date 06/03/2010
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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