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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Oximeter, Fiber-Optic
510(k) Number K901736
Device Name OXIMETRY PROBE CATHETERS
Applicant
Baxter Healthcare Corp
P O Box 11150
Santa Ana,  CA  92711
Applicant Contact DOUGLAS, PHD
Correspondent
Baxter Healthcare Corp
P O Box 11150
Santa Ana,  CA  92711
Correspondent Contact DOUGLAS, PHD
Regulation Number870.1230
Classification Product Code
DQE  
Date Received04/17/1990
Decision Date 09/11/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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