BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    SKYLARK GB 1000

    K Number: K861214 · Decision Jun 18, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    2
    Review Days
    79

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    Basic Information

    Device Name
    SKYLARK GB 1000
    K Number
    K861214
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Peleg Intl. Co.
    Date Received
    March 31, 1986
    Decision Date
    June 18, 1986
    Product Code
    GZJ
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

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    Other Clearances by Peleg Intl. Co.

    K Number Device Name
    K853898 SKYLARK MODEL 1001 TENS DEVICE