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

    FlowStar Touch Digital Mixer Flowmeter

    K Number: K222794 · Decision Jul 28, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    54
    Applicant Total
    2
    Review Days
    315

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    Basic Information

    Device Name
    FlowStar Touch Digital Mixer Flowmeter
    K Number
    K222794
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5330
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baldus Sedation GmbH & Co. KG
    Date Received
    September 16, 2022
    Decision Date
    July 28, 2023
    Product Code
    BZR
    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
    BZR Mixer, Breathing Gases, Anesthesia Inhalation

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    Other Clearances by Baldus Sedation GmbH & Co. KG

    K Number Device Name
    K230987 FlowStar Analog Mixer Flowmeter