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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 K945290
Device Name 8500A PULSE OXIMETER
Original Applicant
2605 fernbrook lane, north
minneapolis,  MN  55447 4755
Original Contact jerry zweigbaum
Regulation Number870.2700
Classification Product Code
Date Received10/31/1994
Decision Date 02/11/1997
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No