BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    GAUNYING INFRARED LAMP

    K Number: K102149 · Decision Aug 13, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    462
    Registration Numbers
    462
    Same Product Code
    228
    Applicant Total
    6
    Review Days
    14

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    Basic Information

    Device Name
    GAUNYING INFRARED LAMP
    K Number
    K102149
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Foshan Gaunying Electronics Co., Ltd.
    Date Received
    July 30, 2010
    Decision Date
    August 13, 2010
    Product Code
    ILY
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    Y

    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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    Other Clearances by Foshan Gaunying Electronics Co., Ltd.

    K Number Device Name
    K140211 ULTRASONIC MESH NEBULIZER
    K132247 ULTRASONIC MESH NEBULIZER
    K121154 ULTRASONIC NEBULIZER
    K110721 GAUNYING INFRARED LAMP
    K101693 GAUNYING INFRARED LAMP MODEL IL50