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

    NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS

    K Number: K072292 · Decision Jan 7, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    24
    Applicant Total
    4
    Review Days
    144

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    Basic Information

    Device Name
    NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS
    K Number
    K072292
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dima Italia Srl
    Date Received
    August 16, 2007
    Decision Date
    January 7, 2008
    Product Code
    NHJ
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NHJ Device, Positive Pressure Breathing, Intermittent

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    Other Clearances by Dima Italia Srl

    K Number Device Name
    K140598 PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC
    K140605 MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC
    K072290 PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS