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K Number
K973106
Device Name
GOLEMB DISPOSABLE BAG MASK RESUSCITATOR
Manufacturer
ALLIED HEALTHCARE PRODUCTS, INC.
Date Cleared
1998-01-29

(163 days)

Product Code
BTM,DEC
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

The Golemb Disposable Bag Mast Resuscitator is a single patient use system for manual resuscitation.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification approval letter for the "Golemb Disposable Bag Mask Resuscitator." This document is a regulatory approval and does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is solely an FDA approval stating the device is substantially equivalent to a predicate device.

§ 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).