BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CO-OXIMETER SOLUTIONS

    K Number: K863825 · Decision Nov 24, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    7
    Applicant Total
    5
    Review Days
    55

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    Basic Information

    Device Name
    CO-OXIMETER SOLUTIONS
    K Number
    K863825
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3220
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    D.R.G. Scientific Industries
    Date Received
    September 30, 1986
    Decision Date
    November 24, 1986
    Product Code
    JKS
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JKS Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide

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