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

    BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM

    K Number: K133149 · Decision Apr 30, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    113
    Applicant Total
    2
    Review Days
    195

    Basic Information

    Device Name
    BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM
    K Number
    K133149
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5665
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MAR COR PURIFICATION, INC.
    Date Received
    October 17, 2013
    Decision Date
    April 30, 2014
    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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    Other Clearances by MAR COR PURIFICATION, INC.

    K Number Device Name
    K110578 MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM