BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent - Subject to Tracking Reg. 🇺🇸 United States

    RATESAVER PLUS

    K Number: K952671 · Decision Aug 18, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    33
    Applicant Total
    3
    Review Days
    67

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    Basic Information

    Device Name
    RATESAVER PLUS
    K Number
    K952671
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent - Subject to Tracking Reg.
    Applicant
    Entracare Corp.
    Date Received
    June 12, 1995
    Decision Date
    August 18, 1995
    Product Code
    LZH
    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
    LZH Pump, Infusion, Enteral

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    Other Clearances by Entracare Corp.

    K Number Device Name
    K964851 ENTRACARE THERMOMTER MODEL 1000
    K925261 NUTRICARE ENTERAL FEEDING TUBE