BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    ST-302 INFRAREX

    K Number: K990233 · Decision Oct 27, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    462
    Registration Numbers
    462
    Same Product Code
    228
    Applicant Total
    20
    Review Days
    275

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    Basic Information

    Device Name
    ST-302 INFRAREX
    K Number
    K990233
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Skylark Device Co., Ltd.
    Date Received
    January 25, 1999
    Decision Date
    October 27, 1999
    Product Code
    ILY
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ILY Lamp, Infrared, Therapeutic Heating

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