BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LORI HEARING AID SIMULATOR

    K Number: K964080 · Decision Jan 8, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    6
    Applicant Total
    8
    Review Days
    89

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    Basic Information

    Device Name
    LORI HEARING AID SIMULATOR
    K Number
    K964080
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3330
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Lori Medical Laboratories, Inc.
    Date Received
    October 11, 1996
    Decision Date
    January 8, 1997
    Product Code
    KHL
    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
    KHL Hearing Aid, Master

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    Other Clearances by Lori Medical Laboratories, Inc.

    K Number Device Name
    K973376 LORI/LORI, LORI-S (LORI STOCK AID)
    K972058 LORIPRO, LORIPRO II
    K952711 LORI-A
    K940639 LORI-CIC HEARING AID
    K893721 LORI-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENT
    K893722 LORI-MODEL H, HALF CONCHA IN-THE-EAR INSTRUMENT
    K893723 LORI-MODEL L, CANAL IN-THE-EAR INSTRUMENT