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

    AUDICRAFT VIP HEARING AID

    K Number: K820833 · Decision Apr 9, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    8
    Review Days
    14

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    Basic Information

    Device Name
    AUDICRAFT VIP HEARING AID
    K Number
    K820833
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Audina Hearing Instrument
    Date Received
    March 26, 1982
    Decision Date
    April 9, 1982
    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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    K936190 BEHIND THE EAR HEARING AID
    K930271 BEHIND-THE-EAR HEARING AID
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    K897023 OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID