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

    MARK5 ARTERIAL BLOOD GAS KIT

    K Number: K841810 · Decision Jul 6, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    7
    Review Days
    66

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    Basic Information

    Device Name
    MARK5 ARTERIAL BLOOD GAS KIT
    K Number
    K841810
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Martell Medical Products, Inc.
    Date Received
    May 1, 1984
    Decision Date
    July 6, 1984
    Product Code
    FMF
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FMF Syringe, Piston

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    Other Clearances by Martell Medical Products, Inc.

    K Number Device Name
    K945454 LEUR TIP CAP, VLT CAP(TM)
    K944941 PISTON SYRINGE
    K822786 MDM ARTERIAL BLOOD GAS KIT
    K822760 ARTERIAL LINE KIT
    K821096 A-LINER
    K812560 MDM ARTERIAL BLOOD GAS SYRINGE