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

    SD-100 SKYEAR THERMOMETER

    K Number: K984506 · Decision Jul 29, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    20
    Review Days
    223

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    Basic Information

    Device Name
    SD-100 SKYEAR THERMOMETER
    K Number
    K984506
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Skylark Device Co., Ltd.
    Date Received
    December 18, 1998
    Decision Date
    July 29, 1999
    Product Code
    FLL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FLL Continuous Measurement Thermometer

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    Other Clearances by Skylark Device Co., Ltd.

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    K963729 SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD)
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