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

    COMPUTON(R)

    K Number: K863200 · Decision Sep 3, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    37
    Same Product Code
    57
    Applicant Total
    3
    Review Days
    15

    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
    COMPUTON(R)
    K Number
    K863200
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1930
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Optical Radiation Corp.
    Date Received
    August 19, 1986
    Decision Date
    September 3, 1986
    Product Code
    HKX
    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
    HKX Tonometer, Ac-Powered

    Similar 510(k) Clearances

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

    AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VS Tabletop Tonometer

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Intraocular Pressure Tonometer EASYTON

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MiiS Horus Scope DPT 100

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Keeler TonoCare Tonometer

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Tono Vue Non-Contact Tonometer

    FDA 510(k)
    FDA Class 2 ·Ophthalmic
    View all

    Other Clearances by Optical Radiation Corp.

    K Number Device Name
    K920795 0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX
    K853668 ORC ORACLE