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

    PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL

    K Number: K993058 · Decision Jan 24, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    17
    Applicant Total
    3
    Review Days
    133

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    Basic Information

    Device Name
    PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL
    K Number
    K993058
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pure Water, Inc.
    Date Received
    September 13, 1999
    Decision Date
    January 24, 2000
    Product Code
    FIN
    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
    FIN Tank, Holding, Dialysis

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    Other Clearances by Pure Water, Inc.

    K Number Device Name
    K993272 PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM
    K992786 PURE WATER, INC.'S WATER PURIFICATION SYSTEMS