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FDA 510(k) Application Details - K001543
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K001543
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
WELCH ALLYN, INC.
4341 STATE ST. RD.
P.O. BOX 220
SKANEATELES FALLS, NY 13153-0220 US
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Contact
ZORAN PSENICNIK
Other 510(k) Applications for this Contact
Regulation Number
870.1130
More FDA Info for this Regulation Number
Classification Product Code
DXN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/17/2000
Decision Date
01/29/2001
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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