LogoFDA 510(k) Search
K Number
K014071
Device Name
PMX DISPOSABLE BAG MASK RESUSCITATOR
Manufacturer
ALLIED HEALTHCARE PRODUCTS, INC.
Date Cleared
2002-10-01

(295 days)

Product Code
BTM
Regulation Number
868.5915
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The PMX Disposable Bag Mask Resuscitator are manual resuscitators incorporating a bag and valve, intended to provide emergency ventilation or ventilation during patient transport. The child model is intended for patients weighting between 10 and 40 kg and the adult model is intended for patients weighting more than 40 kg approximate weight.

Device Description

manual resuscitators incorporating a bag and valve

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a manual emergency ventilator. It does not contain any information about acceptance criteria or a study demonstrating the device meets those criteria.

The letter primarily:

  • Confirms the device (PMX Disposable Bag Mask Resuscitator) is substantially equivalent to a predicate device.
  • Outlines general regulatory requirements for the manufacturer.
  • States the intended use of the device.

Therefore, I cannot extract the requested information based on the input text.

§ 868.5915 Manual emergency ventilator.

(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).