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

    EARCLEAR

    K Number: K951596 · Decision May 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    47

    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
    EARCLEAR
    K Number
    K951596
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arisil Medical
    Date Received
    April 7, 1995
    Decision Date
    May 24, 1995
    Product Code
    MJV
    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
    MJV Device, Inflation, Middle Ear

    Similar 510(k) Clearances

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

    Earflo (EF001)

    FDA 510(k)
    FDA Unclassified ·Unknown

    Ear Pressure Relief Device(Model:ER813B)

    FDA 510(k)
    FDA Unclassified ·Unknown

    Eustachi Ear Pressure Relief Device

    FDA 510(k)
    FDA Unclassified ·Unknown

    EARPOPPER, MODEL EP-2000, EP-2100, EP-3000

    FDA 510(k)
    FDA Unclassified ·Unknown

    OTOVENT

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all