FDA 510(k) Application Details - K942543

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

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510(K) Number K942543
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant SANKEI CO., LTD.
2126 BERWICK
INVERNESS, IL US
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Contact BRUCE SHULLO
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 04/25/1994
Decision Date 07/14/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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