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

    ACOUSTIQ LISTENING DEVICE

    K Number: K904755 · Decision Jan 29, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    102

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ACOUSTIQ LISTENING DEVICE
    K Number
    K904755
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3320
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Krueger Laboratories
    Date Received
    October 19, 1990
    Decision Date
    January 29, 1991
    Product Code
    LZI
    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
    LZI Device, Assistive Listening

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LZI), ordered by most recent decision date.

    EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    POCKETALKER PRO

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    LISTENAIDER II

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    HEARIT

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat
    View all