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

    STRIPE PROJECTOR

    K Number: K902138 · Decision Jul 5, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    56

    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
    STRIPE PROJECTOR
    K Number
    K902138
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1395
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Academic Catalyst Corp.
    Date Received
    May 10, 1990
    Decision Date
    July 5, 1990
    Product Code
    HJI
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HJI Lens, Fundus, Hruby, Diagnostic

    Similar 510(k) Clearances

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

    BYRNE EXPULSIVE LENS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    60 FUNDUS CAMERA CF-60UV

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    LASER IMAGING WORK STATION

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    OMS QUARTZ INFUSION CONTACT LENS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    SEBESTYEN IRRIGATING CONTACT LENS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    LANDERS CONTACT LENS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic
    View all