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K Number
K981307
Device Name
INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR
Manufacturer
INTERNATIONAL RESPIRATORY SYSTEMS, INC.
Date Cleared
1998-07-06

(87 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 International Respiratory Systems, Inc's Manual Resuscitator is designed to provide The International respence of reversible apnea, commonly associated with cardiopulmonary arrest.

Device Description

International Respiratory Systems, Inc.'s Manual Resuscitator

AI/ML Overview

I am sorry, but the provided document is a 510(k) clearance letter from the FDA for a Manual Pulmonary Resuscitator. It confirms that the device is substantially equivalent to legally marketed predicate devices.

This document does not contain information about:

  • Acceptance criteria and reported device performance in a table format.
  • Details of a study proving the device meets acceptance criteria, including sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
  • Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot fulfill your request based on the provided 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).