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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name computer, diagnostic, pre-programmed, single-function
510(k) Number K893392
Device Name CPM-1 SYSTEM 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 Number870.1435
Classification Product Code
DXG  
Date Received05/01/1989
Decision Date 06/20/1989
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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