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

    ETA

    K Number: K883853 · Decision Nov 17, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    65

    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
    ETA
    K Number
    K883853
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Sevrain-Tech, Inc.
    Date Received
    September 13, 1988
    Decision Date
    November 17, 1988
    Product Code
    LRA
    Advisory Committee
    Unknown
    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
    LRA Hearing Aid, Tactile

    Similar 510(k) Clearances

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

    WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER

    FDA 510(k)
    FDA Unclassified ·Unknown

    TACTICON 1600

    FDA 510(k)
    FDA Unclassified ·Unknown

    TEACHER TM

    FDA 510(k)
    FDA Unclassified ·Unknown

    KANIEVSKI SENSORY AID OR DEVICE

    FDA 510(k)
    FDA Unclassified ·Unknown

    TACTIL EAR

    FDA 510(k)
    FDA Unclassified ·Unknown

    TACTAID

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Sevrain-Tech, Inc.

    K Number Device Name
    K884540 ETV, ELECTRONIC VISION AID