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

    ELPER(TM) BARRIER INTEGRITY MONITORING

    K Number: K931153 · Decision Nov 18, 1993
    View on FDA
    Classifications
    0
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    80
    Applicant Total
    1
    Review Days
    254

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    Basic Information

    Device Name
    ELPER(TM) BARRIER INTEGRITY MONITORING
    K Number
    K931153
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Igea, S.R.L.
    Date Received
    March 9, 1993
    Decision Date
    November 18, 1993
    Product Code
    LDQ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    N

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