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

    Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus

    K Number: K221836 · Decision Dec 7, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    201
    Applicant Total
    3
    Review Days
    167

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    Basic Information

    Device Name
    Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus
    K Number
    K221836
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5260
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Drägerwerk AG & Co. KGaA
    Date Received
    June 23, 2022
    Decision Date
    December 7, 2022
    Product Code
    CAH
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CAH Filter, Bacterial, Breathing-Circuit

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