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

    IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE

    K Number: K011586 · Decision Nov 16, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    322
    Same Product Code
    106
    Applicant Total
    7
    Review Days
    177

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    Basic Information

    Device Name
    IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE
    K Number
    K011586
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diametrics Medical, Inc.
    Date Received
    May 23, 2001
    Decision Date
    November 16, 2001
    Product Code
    GAA
    Advisory Committee
    General, Plastic Surgery
    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
    GAA Needle, Aspiration And Injection, Disposable

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    Other Clearances by Diametrics Medical, Inc.

    K Number Device Name
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    K981270 IRMA BLOOD ANALYSIS SYSTEM
    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