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

    Health Expert Electronic Stimulator (model: AST-3000L)

    K Number: K190783 · Decision Mar 14, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    158
    Registration Numbers
    158
    Same Product Code
    216
    Applicant Total
    6
    Review Days
    353

    Basic Information

    Device Name
    Health Expert Electronic Stimulator (model: AST-3000L)
    K Number
    K190783
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen OSTO Technology Company Limited
    Date Received
    March 27, 2019
    Decision Date
    March 14, 2020
    Product Code
    NUH
    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
    NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

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