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510(k) Data Aggregation

    K Number
    K992902
    Device Name
    AMBU HAND POWER SUCTION PUMP
    Manufacturer
    AMBU, INC.
    Date Cleared
    1999-10-25

    (56 days)

    Product Code
    BSY,BYY,KTR
    Regulation Number
    868.6810
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AMBU HAND POWER SUCTION PUMP

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

    Ambu Suction Pump is intended for quick suction of fluids from the nose and mouth of children and adult as well as for amnionic fluids from the newborn.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) clearance letter from the FDA for a medical device. It does not include information on acceptance criteria or a study proving the device meets those criteria. Such information would typically be found in the 510(k) submission itself, not the clearance letter.

    Therefore, I cannot provide the requested information based only on the provided text. The document confirms the device is substantially equivalent to a predicate device, which is the basis for its market clearance, but doesn't detail performance studies or acceptance criteria it might have undergone.

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