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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 K000664
Device Name VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS
Applicant
BAXTER HEALTHCARE CORP.
17221 RED HILL AVE.
PO BOX 11150
IRVINE,  CA  92614 -5627
Applicant Contact PAULA A TORRIANNI
Correspondent
BAXTER HEALTHCARE CORP.
17221 RED HILL AVE.
PO BOX 11150
IRVINE,  CA  92614 -5627
Correspondent Contact PAULA A TORRIANNI
Regulation Number870.1435
Classification Product Code
DXG  
Date Received02/28/2000
Decision Date 09/20/2000
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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