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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name blood pressure cuff
510(k) Number K122058
Device Name FLEXIPORT ECOCUFF
Original Applicant
WELCH ALLYN, INC.
4341 state st. rd.
p.o. box 220
skaneateles falls,  NY  13153 -0220
Original Contact kevin crossen
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received07/13/2012
Decision Date 11/05/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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