BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Intra.Ox Handheld Tissue Oximeter

    K Number: K163472 · Decision Nov 16, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    73
    Applicant Total
    8
    Review Days
    339

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    Basic Information

    Device Name
    Intra.Ox Handheld Tissue Oximeter
    K Number
    K163472
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vioptix, Inc.
    Date Received
    December 12, 2016
    Decision Date
    November 16, 2017
    Product Code
    MUD
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MUD Oximeter, Tissue Saturation

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    Other Clearances by Vioptix, Inc.

    K Number Device Name
    K233488 Intra.Ox™ 2.0 Handheld Tissue Oximeter
    K221010 Intra.Ox 2.0 Handheld Tissue Oximeter
    K191676 Intra.Ox 2.0 Handheld Tissue Oximeter
    K133983 INTRA. OX HANDHELD TISSUE OXIMETER
    K141234 ODISSEY TISSUE OXIMETER
    K090679 VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM
    K042657 VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2