BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    Besmed Reusable Jet Nebulizer

    K Number: K150591 · Decision Jun 30, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    10
    Review Days
    113

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    Basic Information

    Device Name
    Besmed Reusable Jet Nebulizer
    K Number
    K150591
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Besmed Health Business Corp
    Date Received
    March 9, 2015
    Decision Date
    June 30, 2015
    Product Code
    CAF
    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
    CAF Nebulizer (Direct Patient Interface)

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    Other Clearances by Besmed Health Business Corp

    K Number Device Name
    K241339 Besmed Bacterial Filter and HMEF
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    K160112 Besmed PEEP Valve
    K143150 CO2 monitoring line with and without in-line filter
    K140370 DISPOSABLE PRESSURE MANOMETER
    K133873 TRIBALL INCENTIVE SPIROMETER
    K091272 BESMED JET NEBULIZER BOTTLE SET
    K031374 BESMED VARIOUS MODELS OF TENS, BE-550/BE-660
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