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

    CMR 300, ROWATER TREATMENT UNIT

    K Number: K802474 · Decision Dec 15, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    116
    Applicant Total
    1
    Review Days
    67

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    Basic Information

    Device Name
    CMR 300, ROWATER TREATMENT UNIT
    K Number
    K802474
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5665
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    U-Marc, Inc.
    Date Received
    October 9, 1980
    Decision Date
    December 15, 1980
    Product Code
    FIP
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FIP Subsystem, Water Purification

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