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510(k) Data Aggregation

    K Number
    K971749
    Device Name
    EASYGO ASPIRATOR
    Manufacturer
    PRECISION MEDICAL, INC.
    Date Cleared
    1998-04-01

    (324 days)

    Product Code
    BTA
    Regulation Number
    878.4780
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K140179,K201203
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EASy So Aspirator PROVIDES A PORTABLE, BATTERY POWER MEDICAL VALUAM SOLICE. THE EXELLIGO ASPIRATOR CAN ALSO BE POWERED FRIM A STANDARD WALL GUTLET WITH THE USE OF IN AC POWER ADAPTER. IT IS INTENDED FOR USE IN THE HOME CARE OF HOSPITAL ENVIRONMENT

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but without a study or performance data, I cannot provide information on acceptance criteria or device performance. The provided document is a 510(k) clearance letter from the FDA for a device called "EasyGo Aspirator" and does not contain the details of a study or performance metrics. It indicates that the device is substantially equivalent to legally marketed predicate devices, but it does not include a table of acceptance criteria or reported device performance.

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