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FDA 510(k) Application Details - K052784
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K052784
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
CHRIS KLACZKY
Other 510(k) Applications for this Contact
Regulation Number
870.1130
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Classification Product Code
DXN
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More FDA Info for this Product Code
Date Received
10/03/2005
Decision Date
11/22/2005
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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