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

    IRMA BLOOD ANALYSIS SYSTEM

    K Number: K981270 · Decision May 1, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    37
    Applicant Total
    7
    Review Days
    24

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    Basic Information

    Device Name
    IRMA BLOOD ANALYSIS SYSTEM
    K Number
    K981270
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1170
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diametrics Medical, Inc.
    Date Received
    April 7, 1998
    Decision Date
    May 1, 1998
    Product Code
    CGZ
    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
    CGZ Electrode, Ion-Specific, Chloride

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    Other Clearances by Diametrics Medical, Inc.

    K Number Device Name
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    K011586 IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE
    K980523 IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE
    K974396 IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE
    K945240 IRMA BLOOD ANALYSIS SYSTEM