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

    ABIOMED BODY LEAD ANALYZER MODEL 200/20

    K Number: K900574 · Decision Mar 15, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    19
    Review Days
    36

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    Basic Information

    Device Name
    ABIOMED BODY LEAD ANALYZER MODEL 200/20
    K Number
    K900574
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1220
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Abiomed, Inc.
    Date Received
    February 7, 1990
    Decision Date
    March 15, 1990
    Product Code
    JAO
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JAO Scanner, Fluorescent

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