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

    INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH.

    K Number: K902627 · Decision Feb 25, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    36
    Applicant Total
    2
    Review Days
    257

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    Basic Information

    Device Name
    INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH.
    K Number
    K902627
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1915
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Biometric Research Institute, Inc.
    Date Received
    June 13, 1990
    Decision Date
    February 25, 1991
    Product Code
    KRB
    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
    KRB Probe, Thermodilution

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    Other Clearances by Biometric Research Institute, Inc.

    K Number Device Name
    K902628 INTERFLO MEDICAL MODEL INTERFLO/1 CARDIAC OUTPUT