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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name oximeter
510(k) Number K053381
Device Name WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE
Original Applicant
WELCH ALLYN, INC.
4341 state st. rd.
p.o. box 220
skaneateles falls,  NY  13153 0220
Original Contact chris klaczyk
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/05/2005
Decision Date 06/15/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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