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

    MAXI-FLOW INSUFFLATOR TUBING SET W/FILTER

    K Number: K903209 · Decision Dec 21, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    12
    Applicant Total
    8
    Review Days
    154

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    Basic Information

    Device Name
    MAXI-FLOW INSUFFLATOR TUBING SET W/FILTER
    K Number
    K903209
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Adler Instrument Co.
    Date Received
    July 20, 1990
    Decision Date
    December 21, 1990
    Product Code
    HES
    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
    HES Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)

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    Other Clearances by Adler Instrument Co.

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    K910170 MAXI-FLOW SUCTION SET 12 FT.
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    K900913 ADLER DISPOSABLE BIPOLAR CORD
    K841723 ADLER CUSTOM PROCEDURE PACKS
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