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K Number
K982215
Device Name
MANUAL RESUSCITATOR WITH ACE
Manufacturer
MEDICAL MARKETING CONCEPTS
Date Cleared
1998-09-18

(87 days)

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

Manual ventilation and assist in verification of endotracheal tube placement

Device Description

Manual Resuscitator with ACE

AI/ML Overview

I am sorry, but the provided text from the FDA document (K982215) is a letter regarding the substantial equivalence determination for a "Manual Resuscitator with ACE" device. It does not contain any information about acceptance criteria, study data, sample sizes, ground truth establishment, or any performance metrics for the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given information. The document is a regulatory approval letter, not a scientific study report.

§ 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).