FDA 510(k) Application Details - K993890

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

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510(K) Number K993890
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant NIHON SEIMITSU SOKKI CO., LTD.
222 INSTITUTE ST.
SMITHFIELD, VA 23430 US
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Contact ROBERT D WAXHAM
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 11/16/1999
Decision Date 12/01/1999
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 Y
Expedited Review



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