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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Flow Directed
510(k) Number K955816
Device Name VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR
Applicant
Baxter Healthcare Corp
17221 Red Hill Ave.
P.O. Box 11150
Irvine,  CA  92614
Applicant Contact IRENE P PARKER
Correspondent
Baxter Healthcare Corp
17221 Red Hill Ave.
P.O. Box 11150
Irvine,  CA  92614
Correspondent Contact IRENE P PARKER
Regulation Number870.1240
Classification Product Code
DYG  
Date Received12/26/1995
Decision Date 05/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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