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

    WINDSOR MEDICAL VARIOUS MODELS

    K Number: K832606 · Decision Nov 29, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    9
    Review Days
    118

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    Basic Information

    Device Name
    WINDSOR MEDICAL VARIOUS MODELS
    K Number
    K832606
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Windsor Medical, Inc.
    Date Received
    August 3, 1983
    Decision Date
    November 29, 1983
    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 Windsor Medical, Inc.

    K Number Device Name
    K841481 WINDSOR MEDICAL MODEL 50-00002
    K832641 WINDSOR MEDICAL MODEL 52
    K830657 AMBULATORY MARK XI DRUG INFUSION DEV-
    K830656 AMBULATORY MARK III INFUSION DEVICE
    K830490 MODEL 50-01-27
    K830544 WINDSOR MEDICAL, INC. 50-01-028
    K830317 INFUSION PUMP ACCESS. #60-01-5
    K822842 AMBULATORY MARK I