BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    PANORET, MODEL 1000A

    K Number: K001111 · Decision Jul 7, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    5
    Applicant Total
    11
    Review Days
    92

    Basic Information

    Device Name
    PANORET, MODEL 1000A
    K Number
    K001111
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1780
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CMT MEDICAL TECHNOLOGIES, LTD.
    Date Received
    April 6, 2000
    Decision Date
    July 7, 2000
    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.

    STREAK RETINOSCOPE RX-1

    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 CMT MEDICAL TECHNOLOGIES, LTD.

    K Number Device Name
    K162224 ArtPix Mobile EZ2GO
    K110849 PRESTODR 4143
    K103038 DUET DRF
    K100400 PRESTODR PORTABLE
    K080890 SMARTSPOT PRIMAX
    K003438 SMART RAD
    K991578 SMARTSPOT 2000
    K961140 FLUOROPLUS CARDIAC TV
    K961307 SMART SPOT
    K953950 FLUORO CATHETER
    Search all 11 clearances from CMT MEDICAL TECHNOLOGIES, LTD. →