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

    Propeller Sensor Model 2015-E

    K Number: K161454 · Decision Nov 1, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    6
    Review Days
    159

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    Basic Information

    Device Name
    Propeller Sensor Model 2015-E
    K Number
    K161454
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Reciprocal Labs Corporation
    Date Received
    May 26, 2016
    Decision Date
    November 1, 2016
    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 Reciprocal Labs Corporation

    K Number Device Name
    K192724 Propeller Sensor for Symbicort
    K180770 Propeller Sensor for Neohaler
    K142516 Propeller System
    K140638 PROPELLER SYSTEM - MODEL 2
    K121609 ASTHMAPOLIS SYSTEM