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510(k) Data Aggregation

    K Number
    K042727
    Device Name
    POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A
    Manufacturer
    FOREMOUNT ENT. CO., LTD.
    Date Cleared
    2005-03-18

    (168 days)

    Product Code
    CBP
    Regulation Number
    868.5870
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOREMOUNT ENT. CO., LTD.

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

    The Foremount Pocket Size Resuscitator / Model M16201R is indicated for use of The Foremount Pocket oize Nesubonator Amedel with non-rebreathing valve for adult and child whose weight exceeds 10kg. The resuscitator with oxygen port is for prescription use.

    The Foremount Pocket Size Resuscitator / Model M16201A is indicated for use of ter and The Foremount Pocket Size Resulsciator / Model MTF22 MTF mouth to mask ventilation via the ventilation mask with non-rebreathing valve for adult . In mask ventilation via the and child whose weight exceeds 10kg. and child whose worgen oxygen port is for over-the-counter use.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) clearance letter for a medical device, the "Pocket Size Resuscitator," and not a study report describing acceptance criteria and device performance data. Therefore, the requested information about acceptance criteria, performance tables, sample sizes, expert qualifications, and ground truth establishment is not present in the provided text.

    The document primarily states that the FDA has determined the device to be substantially equivalent to legally marketed predicate devices, allowing its marketing. It outlines regulatory requirements the manufacturer must adhere to.

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