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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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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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