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

    SONOMED TECH OPHTHALMIC B-SCAN B-3000

    K Number: K844031 · Decision May 22, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    398
    Registration Numbers
    399
    Same Product Code
    408
    Applicant Total
    5
    Review Days
    219

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    Basic Information

    Device Name
    SONOMED TECH OPHTHALMIC B-SCAN B-3000
    K Number
    K844031
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Sonomed Technology, Inc.
    Date Received
    October 15, 1984
    Decision Date
    May 22, 1985
    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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    Other Clearances by Sonomed Technology, Inc.

    K Number Device Name
    K931908 SONOQUICK ULTRASOUND GEL
    K931909 CLEAR IMAGE STERILE DIAGNOSTIC ULTRSOUND GEL
    K883917 NATURAL IMAGE ULTRASOUND TRANSMISSION COUPLANT
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