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

    EXTRACORPOREAL'S EXP 400 PARALLEL PLATE

    K Number: K802364 · Decision Jan 29, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    35
    Applicant Total
    69
    Review Days
    122

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    Basic Information

    Device Name
    EXTRACORPOREAL'S EXP 400 PARALLEL PLATE
    K Number
    K802364
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Extracorporeal Medical Specialities, Inc.
    Date Received
    September 29, 1980
    Decision Date
    January 29, 1981
    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 Extracorporeal Medical Specialities, Inc.

    K Number Device Name
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    K840262 HANCOCK PERICARDIAL PATCH
    K840146 EXP* 700 PARALLEL PLATE DIALYZER
    K840057 EXP* 500 PARALLEL PLATE DIALYZER
    K831423 THERAPEUTIC EXCHANGE SYSTEM
    K832547 ULTRAFILTRATION CONTROLLER
    K833477 INTERSEPT 40 MICRON FILTER
    K833476 INTERSEPT 40 MICRON FILTER W/TUBING
    K831424 THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101
    Search all 69 clearances from Extracorporeal Medical Specialities, Inc. →