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

    PFIZONIC 100 ULTRASOUND SCANNER

    K Number: K802529 · Decision Dec 18, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    77
    Applicant Total
    12
    Review Days
    63

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    Basic Information

    Device Name
    PFIZONIC 100 ULTRASOUND SCANNER
    K Number
    K802529
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Pfizer Medical Systems, Inc.
    Date Received
    October 16, 1980
    Decision Date
    December 18, 1980
    Product Code
    DXK
    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
    DXK Echocardiograph

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    K801446 PFIZER PZ-CT SCANNER
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