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

    SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001

    K Number: K020641 · Decision Oct 29, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    459
    Applicant Total
    15
    Review Days
    244

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    Basic Information

    Device Name
    SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001
    K Number
    K020641
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Worldwide Medical Technologies, LLC
    Date Received
    February 27, 2002
    Decision Date
    October 29, 2002
    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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