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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 K884329
Device Name SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTER
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 Number870.2700
Classification Product Code
DQA  
Date Received10/14/1988
Decision Date 12/16/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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