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510(k) Data Aggregation

    K Number
    K992481
    Device Name
    CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF
    Manufacturer
    WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH
    Date Cleared
    2000-03-17

    (235 days)

    Product Code
    HET
    Regulation Number
    884.1720
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF

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

    The WISAP CO2-OP-Pneu Computer 7050C/7050CF/7050CM/7050CMF may only be used for building up a pneumoperitoneum with CO2-Gas for diagnostic or operative Pelviscopy/Laparoscopy.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The documents are a 510(k) clearance letter and an indications for use statement for a medical device (WISAP CO2-OP-Pneu Computer). They confirm the FDA's regulatory approval but do not detail the specific performance acceptance criteria or the study data that led to this approval.

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