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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.
P.O. Box 11150
Irvine,  CA  92614
Applicant Contact PAULA A TORRIANNI
Correspondent
Baxter Healthcare Corp
17221 Red Hill Ave.
P.O. Box 11150
Irvine,  CA  92614
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
Predetermined Change
Control Plan Authorized		 No
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