BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MAGNATONE / STERLING/ ST; MAGNATONE/DB; MAGNATONE/ LIBERTY/ LB; MAGNATONE/ PEARL/PH C.I.C., S.P.I., ONE TOUCH, DESIGNER

    K Number: K973665 · Decision Nov 4, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    8
    Review Days
    40

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    Basic Information

    Device Name
    MAGNATONE / STERLING/ ST; MAGNATONE/DB; MAGNATONE/ LIBERTY/ LB; MAGNATONE/ PEARL/PH C.I.C., S.P.I., ONE TOUCH, DESIGNER
    K Number
    K973665
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Magnatone Hearing Aid Corp.
    Date Received
    September 25, 1997
    Decision Date
    November 4, 1997
    Product Code
    ESD
    Advisory Committee
    Ear, Nose, Throat
    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
    ESD Hearing Aid, Air-Conduction, Prescription

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    Other Clearances by Magnatone Hearing Aid Corp.

    K Number Device Name
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    K944241 MAGNATONE MODEL M PREWIRED FACEPLATE HEARING AID
    K911183 NHS 2044P BODY AID, HEARING AID
    K911182 NNHS 2050 SERIES (2055W-2054PP) HEARING AIDS
    K911174 NHS 2009SP HEARING AID
    K890525 INTERTON BTE HEAR AID, SUPRA, SUPREMA, MINETTA
    K852656 MODEL M HEARING AID