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

    DMI BLOD GAS ANALYZER/CARTRIDGE

    K Number: K915087 · Decision Jan 8, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    187
    Applicant Total
    6
    Review Days
    57

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    Basic Information

    Device Name
    DMI BLOD GAS ANALYZER/CARTRIDGE
    K Number
    K915087
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1120
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Diamond Medical, Inc.
    Date Received
    November 12, 1991
    Decision Date
    January 8, 1992
    Product Code
    CHL
    Advisory Committee
    Clinical Chemistry
    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
    CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

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    Other Clearances by Diamond Medical, Inc.

    K Number Device Name
    K924758 DMI BLOOD GAS ANALYZER/CARTRIDGE
    K874710 DIAMOND MEDICAL, INC. MODEL DM 600
    K874709 DIAMOND MEDICAL, INC. MODEL DM 800
    K875369 MODEL ISO-2001 UNIV. PATIENT ISOLATION CIRCUIT
    K863298 DIAMOND MEDICAL, INC., MODEL DM 700