BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    HI-TEC CO2 INSUFFLATOR TYPE 1300

    K Number: K955477 · Decision Aug 6, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    176
    Applicant Total
    2
    Review Days
    615

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    Basic Information

    Device Name
    HI-TEC CO2 INSUFFLATOR TYPE 1300
    K Number
    K955477
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1730
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz
    Date Received
    November 30, 1995
    Decision Date
    August 6, 1997
    Product Code
    HIF
    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
    HIF Insufflator, Laparoscopic

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    Other Clearances by Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz

    K Number Device Name
    K930013 CO2 INSUFFLATOR 1100