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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 (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No