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

    BEELINE MOTIV, PROPOLIS, PCA

    K Number: K042228 · Decision Nov 8, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    7
    Review Days
    83

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    Basic Information

    Device Name
    BEELINE MOTIV, PROPOLIS, PCA
    K Number
    K042228
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mckinley, Inc.
    Date Received
    August 17, 2004
    Decision Date
    November 8, 2004
    Product Code
    FRN
    Advisory Committee
    General Hospital
    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
    FRN Pump, Infusion

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    Other Clearances by Mckinley, Inc.

    K Number Device Name
    K033039 MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS
    K032642 BEELINE SYSTEM
    K991275 WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS
    K990461 MCKINLEY SP DISPOSABLE INFUSION PUMP
    K982256 OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP
    K971844 MCKINLEY OUTBOUND-2 SYSTEM