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

    LORI/LORI, LORI-S (LORI STOCK AID)

    K Number: K973376 · Decision Oct 14, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    8
    Review Days
    36

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    Basic Information

    Device Name
    LORI/LORI, LORI-S (LORI STOCK AID)
    K Number
    K973376
    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
    Lori Medical Laboratories, Inc.
    Date Received
    September 8, 1997
    Decision Date
    October 14, 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 Lori Medical Laboratories, Inc.

    K Number Device Name
    K972058 LORIPRO, LORIPRO II
    K964080 LORI HEARING AID SIMULATOR
    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