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

    WINDSOR MEDICAL, INC. 50-01-028

    K Number: K830544 · Decision Mar 31, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    9
    Review Days
    37

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    WINDSOR MEDICAL, INC. 50-01-028
    K Number
    K830544
    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
    February 22, 1983
    Decision Date
    March 31, 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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FRN), ordered by most recent decision date.

    FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SIGMA Spectrum Infusion Pump with Master Drug Library

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MRidium 3870 MRI Infusion Pump System (3870)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD Alaris Infusion System with Guardrails Suite MX

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Plum Solo™ Precision IV Pump

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Windsor Medical, Inc.

    K Number Device Name
    K841481 WINDSOR MEDICAL MODEL 50-00002
    K832606 WINDSOR MEDICAL VARIOUS MODELS
    K832641 WINDSOR MEDICAL MODEL 52
    K830657 AMBULATORY MARK XI DRUG INFUSION DEV-
    K830656 AMBULATORY MARK III INFUSION DEVICE
    K830490 MODEL 50-01-27
    K830317 INFUSION PUMP ACCESS. #60-01-5
    K822842 AMBULATORY MARK I