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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, measurement, blood-pressure, non-invasive
510(k) Number K052784
Device Name DEVICE CONNECTIVITY SOFTWARE DEVELOPERS KIT (SDK), MODEL 4500-900
Applicant
WELCH ALLYN, INC.
4341 STATE ST. RD.
P.O. BOX 220
skaneateles falls,  NY  13153 -0220
Applicant Contact chris klaczky
Correspondent
WELCH ALLYN, INC.
4341 STATE ST. RD.
P.O. BOX 220
skaneateles falls,  NY  13153 -0220
Correspondent Contact chris klaczky
Regulation Number870.1130
Classification Product Code
DXN  
Date Received10/03/2005
Decision Date 11/22/2005
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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