FDA 510(k) Application Details - K010186

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

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510(K) Number K010186
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant WELCH ALLYN, INC.
95 OLD SHOALS RD.
ARDEN, NC 28704 US
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Contact DAVID A YOUNG II
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 01/22/2001
Decision Date 06/08/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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