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

    SCOPE MASTER

    K Number: K811270 · Decision Sep 8, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    170
    Applicant Total
    8
    Review Days
    125

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    Basic Information

    Device Name
    SCOPE MASTER
    K Number
    K811270
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1690
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Synemed, Inc.
    Date Received
    May 6, 1981
    Decision Date
    September 8, 1981
    Product Code
    HIH
    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
    HIH Hysteroscope (And Accessories)

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    Other Clearances by Synemed, Inc.

    K Number Device Name
    K954037 FIELD TREND
    K852936 THE FIELDMASTER MODEL 275
    K833274 DERMATOLOGY HANDPIECE-OPHTH LASER
    K831085 SYNEVAC VACUUM SOURCE UNIT
    K828585 OPTHALAS PHOTOCOAGULATOR
    K822853 MODEL 200 SQUID
    K813282 SYNEVAC VACUUM CURETTAGE SYSTEMS