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510(k) Data Aggregation

    K Number
    K980301
    Device Name
    IP-16
    Manufacturer
    SERVIZI MEDICO ESTETICI ITALINAI SRL.
    Date Cleared
    1998-03-24

    (56 days)

    Product Code
    BTA
    Regulation Number
    878.4780
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    IP-16

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

    1P-16 infiltration/suction pump is indicated for fluid infiltration and aspiration

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called the "Peristaltic Infiltration/Suction Pump" (also referred to as IP-16 Infiltration/Suction Pump).

    This document does not contain any information about acceptance criteria for device performance, a study to prove meeting those criteria, or details regarding the methodologies of such a study.

    The FDA letter confirms that the device is "substantially equivalent" to predicate devices already on the market, signifying its regulatory clearance based on that comparison, not necessarily on a direct performance study detailed within this letter.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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