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

    MAGNATEK 30

    K Number: K991819 · Decision Aug 19, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    7
    Review Days
    84

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    Basic Information

    Device Name
    MAGNATEK 30
    K Number
    K991819
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Magna Advanced Technologies, Inc.
    Date Received
    May 27, 1999
    Decision Date
    August 19, 1999
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    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
    DQA Oximeter

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    Other Clearances by Magna Advanced Technologies, Inc.

    K Number Device Name
    K982907 MAGNATEK 40
    K983114 MAGNATEK80
    K982846 MTEK-1400
    K982405 MTEK-1000
    K981310 MAGNATEK C-300
    K981416 MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15