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510(k) Data Aggregation

    K Number
    K112126
    Device Name
    GENUINE FIRST AID CPR MASK
    Manufacturer
    GENUINE FIRST AID LLC
    Date Cleared
    2011-12-01

    (129 days)

    Product Code
    CBP
    Regulation Number
    868.5870
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K081516,K052458
    Why did this record match?
    Device Name :

    GENUINE FIRST AID CPR MASK

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

    The CPR mask (without oxygen port) is single use designed for mouth to mask ventilation to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques of a non-breathing adult. It is also used as a barrier that will direct expired air from the patient away from the user. This device should only be used by persons who have received adequate training.

    Device Description

    Genuine First Aid CPR Face Mask without oxygen port, is made up of medical grade PVC and one-way valve of medical grade K-resin. The mask is used for mouth-to-mask breathing. There is a shield between the person who gives respiration and the victim. Single use, CPR mask includes: One-way filter valve PVC mask without oxygen port Elastic Strap Packaged for easy portability and quick access

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study information for the Genuine First Aid CPR Mask, based on the provided 510(k) summary:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriterionDevice Performance (Genuine First Aid CPR Mask)Standard/Requirement
    Expiratory resistance3 cmH2O (at 50 L/min)
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