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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 K233488
Device Name Intra.Ox™ 2.0 Handheld Tissue Oximeter
Applicant
Vioptix, Inc.
39655 Eureka Dr.
Newark,  CA  94560
Applicant Contact Scott Coleridge
Correspondent
Veranex, Inc.
224 Airport Pkwy., Suite 250
San Jose,  CA  95110
Correspondent Contact Valerie Defiesta-Ng
Regulation Number870.2700
Classification Product Code
MUD  
Date Received10/27/2023
Decision Date 02/28/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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