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510(k) Data Aggregation

    K Number
    K971307
    Device Name
    AMSCO SURGICAL TABLE
    Manufacturer
    STERIS Corporation
    Date Cleared
    1997-06-27

    (80 days)

    Product Code
    FQO
    Regulation Number
    878.4960
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AMSCO SURGICAL TABLE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AMSCO® Surgical Table is a mobile, electro-hydraulically operated general surgical table that provides flexible articulation and image amplification of the surgical patient.

    Device Description

    mobile, electro-hydraulically operated general surgical table

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot answer your request. The document is an FDA 510(k) clearance letter for a surgical table and does not contain information about the acceptance criteria, study data, or performance metrics of a device, especially not those related to an AI/ML powered device. It merely states that the device is substantially equivalent to a predicate device.

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