LogoFDA 510(k) Search
K Number
K042843
Device Name
AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS
Manufacturer
AMBU, INC.
Date Cleared
2004-11-12

(29 days)

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

The Ambu SPUR II Infant Single Patient Use Resuscitator is intended for pulmonary resuscitation and emergency respiratory support of neonates and infants with a body weight up to 22lbs (10kg).

The Ambu SPUR II Pediatric Single Patient Use Resuscitator is intended for pulmonary resuscitation and emergency respiratory support of infants and children with a body weight up to 66lbs (30kg), approx. 9 years of age.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to Ambu, Inc. regarding their Ambu® SPUR® II resuscitators. This document primarily focuses on regulatory approval and indications for use.

It does not contain any information about:

  • Acceptance criteria for a device's performance regarding a specific study.
  • Results from any studies proving criteria are met.
  • Sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

Therefore, I cannot fulfill your request for this specific information based on the text provided.

§ 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).