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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
510(k) Number K875225
Device Name UMBILICAL ARTERY OXYGEN SENSOR
Applicant
OHMEDA MEDICAL
2007 PAN AM CIRCLE
TAMPA,  FL  33702
Applicant Contact JILL PHILLIPS
Correspondent
OHMEDA MEDICAL
2007 PAN AM CIRCLE
TAMPA,  FL  33702
Correspondent Contact JILL PHILLIPS
Regulation Number868.1200
Classification Product Code
CCE  
Date Received12/22/1987
Decision Date 03/04/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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