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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oximeter, tissue saturation
510(k) Number K042657
FOIA Releasable 510(k) K042657
Device Name VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2
Applicant
VIOPTIX, INC.
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Applicant Contact GREG HOLLAND
Correspondent
VIOPTIX, INC.
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Correspondent Contact GREG HOLLAND
Regulation Number870.2700
Classification Product Code
MUD  
Date Received09/28/2004
Decision Date 01/10/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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