BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    DCR VOLUMETRIC INFUSION PUMP W/ NEW MAINS POWER PK

    K Number: K922074 · Decision Jan 22, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    2
    Review Days
    263

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    Basic Information

    Device Name
    DCR VOLUMETRIC INFUSION PUMP W/ NEW MAINS POWER PK
    K Number
    K922074
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Danby Medical , Ltd.
    Date Received
    May 4, 1992
    Decision Date
    January 22, 1993
    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 Danby Medical , Ltd.

    K Number Device Name
    K912914 DANBY-DCR VOLUMETRIC INFUSION PUMP