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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 K040490
FOIA Releasable 510(k) K040490
Device Name WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE
Applicant
WELCH ALLYN, INC.
4341 STATE ST. RD.
SKANEATELES FALLS,  NY  13153 -0220
Correspondent
WELCH ALLYN, INC.
4341 STATE ST. RD.
SKANEATELES FALLS,  NY  13153 -0220
Regulation Number870.1130
Classification Product Code
DXN  
Date Received02/26/2004
Decision Date 08/18/2004
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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