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

    LORI-A

    K Number: K952711 · Decision Jul 3, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    1366
    Applicant Total
    8
    Review Days
    19

    Basic Information

    Device Name
    LORI-A
    K Number
    K952711
    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
    June 14, 1995
    Decision Date
    July 3, 1995
    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
    K973376 LORI/LORI, LORI-S (LORI STOCK AID)
    K972058 LORIPRO, LORIPRO II
    K964080 LORI HEARING AID SIMULATOR
    K940639 LORI-CIC HEARING AID
    K893723 LORI-MODEL L, CANAL IN-THE-EAR INSTRUMENT
    K893721 LORI-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENT
    K893722 LORI-MODEL H, HALF CONCHA IN-THE-EAR INSTRUMENT