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

    PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS

    K Number: K072290 · Decision May 29, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    20
    Applicant Total
    4
    Review Days
    287

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    Basic Information

    Device Name
    PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS
    K Number
    K072290
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5935
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dima Italia Srl
    Date Received
    August 16, 2007
    Decision Date
    May 29, 2008
    Product Code
    BYT
    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
    BYT Ventilator, External Body, Negative Pressure, Adult (Cuirass)

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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
    K072292 NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS