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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 K022084
Device Name ATLAS MONITOR, MODELS 200,210,220
Original Applicant
4341 state st. rd.
p.o. box 220
skaneateles falls,  NY  13153 0220
Original Contact shawn earle
Regulation Number870.2700
Classification Product Code
Date Received06/27/2002
Decision Date 09/26/2002
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Anesthesiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No