BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇦 Canada

    SONOCA III

    K Number: K942095 · Decision Nov 9, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    116
    Same Product Code
    156
    Applicant Total
    6
    Review Days
    203

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    Basic Information

    Device Name
    SONOCA III
    K Number
    K942095
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Holl Meditronics, Inc.
    Date Received
    April 20, 1994
    Decision Date
    November 9, 1994
    Product Code
    LFL
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LFL Instrument, Ultrasonic Surgical

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    Other Clearances by Holl Meditronics, Inc.

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    K901737 SONOCA II ULTRASONIC SURGICAL DEVICE
    K893926 SONOCA ULTRASONIC SURGICAL SYSTEM