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

    ABCOM 2000

    K Number: K912562 · Decision Jan 9, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    136
    Applicant Total
    3
    Review Days
    212

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    Basic Information

    Device Name
    ABCOM 2000
    K Number
    K912562
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Applied Biometrics, Inc.
    Date Received
    June 11, 1991
    Decision Date
    January 9, 1992
    Product Code
    DPW
    Advisory Committee
    Cardiovascular
    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
    DPW Flowmeter, Blood, Cardiovascular

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    Other Clearances by Applied Biometrics, Inc.

    K Number Device Name
    K911320 EXTRAVASCULAR DOPPLER (EVD) ULTRA BLOOD FLOW PROBE
    K870857 ABCOM 1 CARDIAC OUTPUT MONITOR