BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    HEARSAVER

    K Number: K962292 · Decision Oct 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    13
    Applicant Total
    2
    Review Days
    137

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    Basic Information

    Device Name
    HEARSAVER
    K Number
    K962292
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Emtech Laboratories
    Date Received
    June 14, 1996
    Decision Date
    October 29, 1996
    Product Code
    EWD
    Advisory Committee
    Unknown
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EWD Protector, Hearing (Insert)

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    Other Clearances by Emtech Laboratories

    K Number Device Name
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