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

    INVACARE POLARIS EX CPAP, MODEL ISP3000

    K Number: K031064 · Decision Mar 12, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    459
    Applicant Total
    111
    Review Days
    344

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    Basic Information

    Device Name
    INVACARE POLARIS EX CPAP, MODEL ISP3000
    K Number
    K031064
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Invacare Corp.
    Date Received
    April 3, 2003
    Decision Date
    March 12, 2004
    Product Code
    BZD
    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
    BZD Ventilator, Non-Continuous (Respirator)

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