BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    AQUABOSS ECORO DIA 50

    K Number: K032004 · Decision Oct 2, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    116
    Applicant Total
    1
    Review Days
    94

    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
    AQUABOSS ECORO DIA 50
    K Number
    K032004
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5665
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lauer Ltd., Hong Kong
    Date Received
    June 30, 2003
    Decision Date
    October 2, 2003
    Product Code
    FIP
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    FIP Subsystem, Water Purification

    Similar 510(k) Clearances

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

    AquaC UNO H

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DIASAFEplusUS (F00013010)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    AquaA

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    UPT Series Medical RO Water Treatment System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    AquaBplus; AquaB LITE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    AQUAbase nX

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all