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

    WIDEX MODEL SENSO DIGITAL (C9)

    K Number: K965254 · Decision Mar 12, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    52
    Review Days
    72

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    Basic Information

    Device Name
    WIDEX MODEL SENSO DIGITAL (C9)
    K Number
    K965254
    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
    Widex Hearing Aid Co., Inc.
    Date Received
    December 30, 1996
    Decision Date
    March 12, 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 Widex Hearing Aid Co., Inc.

    K Number Device Name
    K080955 ZEN PROGRAM (MIND 440 HEARING AID)
    K971535 WIDEX SENSO DIGITAL (MINI CANAL)
    K970904 WIDEX SENSO DIGITAL (CIC)
    K965218 SENSO DIGITAL (C18)
    K955879 WIDEX MODEL SENSO DIGITAL (C16)
    K955878 WIDEX MODEL SENSO DIGITAL (C8)
    K954526 WIDEX SENSO DIGITAL (PX)
    K952229 WIDEX MODEL LOGO 32 (L32)
    K946071 LX-ITC
    K944518 WIDEX MODEL LOGO 8S
    Search all 52 clearances from Widex Hearing Aid Co., Inc. →