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

    AHCS HEMOPERFUSION SYSTEM

    K Number: K971015 · Decision Oct 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    216

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    Basic Information

    Device Name
    AHCS HEMOPERFUSION SYSTEM
    K Number
    K971015
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5870
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    American Health Care Systems, Inc.
    Date Received
    March 20, 1997
    Decision Date
    October 22, 1997
    Product Code
    FLD
    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
    FLD Apparatus, Hemoperfusion, Sorbent

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