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

    GAMBRO LUNDIA PRO 200 DIALYZER

    K Number: K933680 · Decision Aug 26, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    35
    Applicant Total
    14
    Review Days
    393

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    Basic Information

    Device Name
    GAMBRO LUNDIA PRO 200 DIALYZER
    K Number
    K933680
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cobe Renal Care, Inc.
    Date Received
    July 29, 1993
    Decision Date
    August 26, 1994
    Product Code
    FJG
    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
    FJG Dialyzer, Parallel Flow

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    Other Clearances by Cobe Renal Care, Inc.

    K Number Device Name
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    K955592 COBE CENTRYSYSTEM 14 PES HEMODIALYZERS
    K955487 GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS
    K946279 PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
    K954003 COBE HEMODYNAMIC RECIRCULATION MONITOR
    K960474 COBE CENTRYSYSTEM 600 HG HEMODIALYZERS
    K944436 COBE CENTRYSYSTEM CS 200 DIALYZER
    K951311 GAMBRO HC 14R HEMOCONCENTRATOR
    K952342 GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS
    K945747 GAMBRO LUNDIA 94-600 DIALYZER
    Search all 14 clearances from Cobe Renal Care, Inc. →