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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 K855027
Device Name PULSE OXIMETER
Original Applicant
PHYSIO-CONTROL CORP.
11811 willows rd. n.e.
p.o. box 97006
redmond,  WA  98073 -9706
Original Contact gail e nova
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/16/1985
Decision Date 05/16/1986
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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