BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    6.0 MHZ LA6060 TRANSDUCER & 4.0 MHZ LA4011 TRANSDU

    K Number: K844772 · Decision Apr 17, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    398
    Registration Numbers
    399
    Same Product Code
    408
    Applicant Total
    111
    Review Days
    498

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    Basic Information

    Device Name
    6.0 MHZ LA6060 TRANSDUCER & 4.0 MHZ LA4011 TRANSDU
    K Number
    K844772
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Philips Medical Systems, Inc.
    Date Received
    December 5, 1984
    Decision Date
    April 17, 1986
    Product Code
    ITX
    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
    ITX Transducer, Ultrasonic, Diagnostic

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