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

    LM-1Z ZOOM SCOPE

    K Number: K902313 · Decision Sep 4, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    55
    Applicant Total
    10
    Review Days
    104

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    Basic Information

    Device Name
    LM-1Z ZOOM SCOPE
    K Number
    K902313
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1630
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Leisegang Medical, Inc.
    Date Received
    May 23, 1990
    Decision Date
    September 4, 1990
    Product Code
    HEX
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HEX Colposcope (And Colpomicroscope)

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    Other Clearances by Leisegang Medical, Inc.

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    K924134 LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS
    K920217 MAX-E-VAC
    K914201 LM- LAP 10 HIGH FLOW INSUFFLATOR
    K912789 LM-100/200LOW FLOW INSUFFLATOR
    K913135 LM-300TWIN
    K911212 LM-150HT LIGHT SOURCE
    K854767 LM 1000