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

    EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH

    K Number: K926450 · Decision Feb 22, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    18
    Applicant Total
    505
    Review Days
    60

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    Basic Information

    Device Name
    EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH
    K Number
    K926450
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1230
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Baxter Healthcare Corp
    Date Received
    December 24, 1992
    Decision Date
    February 22, 1993
    Product Code
    DQE
    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
    DQE Catheter, Oximeter, Fiber-Optic

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