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

    PNEUMOCLEAR

    K Number: K201361 · Decision Jul 29, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    142
    Registration Numbers
    142
    Same Product Code
    174
    Applicant Total
    2
    Review Days
    68

    Basic Information

    Device Name
    PNEUMOCLEAR
    K Number
    K201361
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1730
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    W.O.M. WORLD OF MEDICINE GmbH
    Date Received
    May 22, 2020
    Decision Date
    July 29, 2020
    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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