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510(k) Data Aggregation

    K Number
    K974141
    Device Name
    PLUS REUSABLE RESUSCITATOR
    Manufacturer
    SCHIFF & CO.
    Date Cleared
    1998-05-21

    (199 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PLUS REUSABLE RESUSCITATOR

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

    Plus Reusable Resuscitators are intended for use by trained medical personnel to maintain lung ventilation during resuscitation and other critical situations and when natural breathing is insufficient or absent.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for a "Plus Reusable Resuscitator" and primarily discusses the regulatory approval and substantial equivalence to a predicate device. It indicates the device's intended use but does not detail acceptance criteria, performance data, study designs, sample sizes, ground truth establishment, or expert qualifications as typically found in a clinical study report or device performance evaluation.

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