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

    MAGNATEK80

    K Number: K983114 · Decision Sep 22, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    7
    Review Days
    18

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    Basic Information

    Device Name
    MAGNATEK80
    K Number
    K983114
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Magna Advanced Technologies, Inc.
    Date Received
    September 4, 1998
    Decision Date
    September 22, 1998
    Product Code
    CCK
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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    Other Clearances by Magna Advanced Technologies, Inc.

    K Number Device Name
    K991819 MAGNATEK 30
    K982907 MAGNATEK 40
    K982846 MTEK-1400
    K982405 MTEK-1000
    K981310 MAGNATEK C-300
    K981416 MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15