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

    VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV

    K Number: K880259 · Decision Apr 3, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    437

    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
    VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV
    K Number
    K880259
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1050
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Colorado Hearing Systems, Inc.
    Date Received
    January 22, 1988
    Decision Date
    April 3, 1989
    Product Code
    LYN
    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
    LYN Apparatus, Visual Reinforcement Audiometric

    Similar 510(k) Clearances

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

    SENSICARE SYNTHETIC, SURGICAL GLOVE LINER

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

    VERA 103

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