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510(k) Data Aggregation

    K Number
    K973610
    Device Name
    SKYVAL
    Manufacturer
    PYRAMID AIR SYSTEMS
    Date Cleared
    1997-12-19

    (88 days)

    Product Code
    FYD
    Regulation Number
    878.5070
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This system is intended The SKYVAC is a central smoke evacuation system. to be used by medical personnel for the purpose of removing smoke generated during operating procedures by laser and electro-surgical units.

    Device Description

    The SKYVAC is a central smoke evacuation system.

    AI/ML Overview

    This document is a 510(k) clearance letter for a medical device called "SKYVAC", a central smoke evacuation system. It does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance metrics.

    Therefore, I cannot provide the requested information. The document focuses solely on the regulatory clearance for the device based on substantial equivalence to pre-existing devices.

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