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

    IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE

    K Number: K980523 · Decision Mar 19, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    187
    Applicant Total
    7
    Review Days
    37

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    Basic Information

    Device Name
    IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE
    K Number
    K980523
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1120
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Diametrics Medical, Inc.
    Date Received
    February 10, 1998
    Decision Date
    March 19, 1998
    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 Diametrics Medical, Inc.

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    K981270 IRMA BLOOD ANALYSIS SYSTEM
    K974396 IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE
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