BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    STREAK RETINOSCOPE RX-1

    K Number: K950789 · Decision Mar 28, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    5
    Applicant Total
    24
    Review Days
    35

    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
    STREAK RETINOSCOPE RX-1
    K Number
    K950789
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1780
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Neitz Instruments Company, Ltd.
    Date Received
    February 21, 1995
    Decision Date
    March 28, 1995
    Product Code
    HKL
    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
    HKL Retinoscope, Ac-Powered

    Similar 510(k) Clearances

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

    PANORET, MODEL 1000A

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    STREAK RETINOSCOPE RX-2

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VISTA STREAK RETINOSCOPE (AC-POWERED)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    KOI BLUE FIELD ENTOPTOSCOPE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MOIRE FRINGE VISOMETER AFTER LOTMAR

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

    Other Clearances by Neitz Instruments Company, Ltd.

    K Number Device Name
    K972440 CATARACTSCREENER CT - S
    K951341 NEITZ SLIT LAMP SL-H2
    K951337 FIBER HEAD LIGHT FH-300
    K950788 OTOSCOPE A-34
    K951340 NEITZ SLIT LAMP SL-H1
    K951338 INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV
    K950792 STREAK RETINOSCOPE RX-3A
    K950797 HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134
    K950793 SPOT RETINOSCOPE RX-3SP
    K950794 STREAK RETINOSCOPE RX-RC
    Search all 24 clearances from Neitz Instruments Company, Ltd. →