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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 K221010
Device Name Intra.Ox 2.0 Handheld Tissue Oximeter
Applicant
Vioptix, Inc.
39655 Eureka Dr.
Newark,  CA  94560
Applicant Contact Scott Coleridge
Correspondent
ViOptix, Inc.
39655 Eureka Dr.
Newark,  CA  94560
Correspondent Contact Mark Lonsinger
Regulation Number870.2700
Classification Product Code
MUD  
Date Received04/05/2022
Decision Date 05/03/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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