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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 K890624
Device Name TISSUE OXYGEN MONITOR SYSTEM, MODEL II
Applicant
BAXTER HEALTHCARE CORP.
P.O. BOX 11150
SANTA ANA,  CA  92711
Applicant Contact EDWARD GUILMETTE
Correspondent
BAXTER HEALTHCARE CORP.
P.O. BOX 11150
SANTA ANA,  CA  92711
Correspondent Contact EDWARD GUILMETTE
Regulation Number868.1200
Classification Product Code
CCE  
Date Received02/07/1989
Decision Date 12/22/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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